Quality

Our team of consultants understand the process within medical device manufacturers, whether the product is hardware, software or diagnostics.

From building quality processes in production locations, establishing new CAPA and auditing systems to Vigilance activities, we spend our working days understanding the role of Quality professionals from start-ups with 10 people to the global players with 15,000+ employees.

Quality Management/Quality Assurance
No two roles in quality management are the same, and we know that each company has it's own challenges, projects and development plans that the QM function will bring to life.

Our network is built strongly on the foundation of knowing ISO 13485 and the documentation required for compliance, and from there understanding your focus in the device lifecycle.

Whether you are working broadly across the QM/RA topics or responsible for medical safety and CAPA - we have seen it all and want to hear about your challenges and aspirations.

CAPA and Validation
​From building new CAPA systems to be compliant with the MDR or establishing a risk management reporting structure compliant to ISO 14971, we know the challenges and project focusses going through the medical device industry at any one time

​Looking at manufacturing process validation and CSV, our network has technical expertise to comply with the quality standards requirements.

PMS and Vigilance
Medical device safety is always at the top of everyone's mind in this industry. Our consultants are constantly updating their knowledge with regards to post-market surveillance requirements, PMS and PSUR reporting.

We have supported candidates to be successful in roles where safety forms part of a broader role, or for larger medical companies who need a dedicated safety professional responsible for a proactive and comprehensive vigilance system.

Auditing and Supplier Quality Assurance
Whether you are looking after the devices during production in QA, responsible for MDSAP implementation or visiting suppliers to ensure they are adhering your company quality assurance agreements, our consultants have covered roles all fields.

We understand the importance of strong negotiation, communication and stakeholder management skills to drive the relationship forward a smooth, compliant route to market.

Watch our video to learn about our recruitment expertise in Quality

 

Active jobs

QA/RA Specialist

Eschborn
Germany
60,000 EUR
QA/RA Specialist QA/RA Specialist for a distributor of interventional catheters and products for lipoprotein apheresis in Eschborn, Germany In this role, you will assist with day-to-day QA activities, particularly in the areas of complaint management and change control for medical devices. Apply now to join my client, the European distributor of a leading manufacturer and supplier of innovative life science products. Role Incentives Competitive Salary that reflects your skills and contributions Flexible Working Options with 40% Home Office Individual training & development opportunities Your Key Responsibilities Complaint handling as the designated Complaint Coordinator Change control activities Verification of purchased and non-conforming products Other Responsibilities Maintenance of device registration database Waste management Requirements Completed studies in Natural Sciences/ Engineering Solid knowledge and previous experience working according to MDR and ISO13485 (Certifications good to have) Min. 1 year experience in Quality Management and Regulatory Affairs, ideally in the areas of complaint management, change control, supplier control, CAPA & non-conformities, product registrations and document management Experience conducting/ participating in audits Fluent German & English (required) Reach out to Vivien Zsuzsanna Urban for more information about the company culture, and long-term development plans. Who Are Adaptive Life Science? Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.   We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.   Why Apply With Us? Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:   Expert advice on your CV and cover letter Guidance on salary expectations Personalized interview preparation Connections to exclusive job opportunities Assistance in negotiating the best possible offers 50% of the CVs we send to clients are accepted Accepted or declined, either way we will provide you with feedback   We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs.   Who Do Adaptive Work With? We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.   If you are interested in this role, please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.   Vivien.urban@adaptivelifescience.com +49 30 16639819  #LI-VU1  

Quality Management Officer (QMB)

Remote
Germany
90,000 EUR
Would you like to drive quality processes for a cutting-edge medical software company?   Are you passionate about contributing to the modernisation and improvement of healthcare?   We're searching for a QMB for our pioneering MedTech client in Munich! Could this be your next step?   Key Responsibilities: Serve as the Quality Management Representative, overseeing all aspects of QMS document management, including creation, revision, and approval processes Lead the CAPA process to ensure timely identification and resolution of non-conformities Coordinate both internal and external audits Provide training and ongoing support to staff on quality-related topics Conduct management reviews to evaluate and report on the compliance and effectiveness of the QMS Draft and evaluate technical documents in line with MDR, regulations for non-EU countries, US FDA 21 CFR Oversee risk management following ISO 14971   Requirements: A degree in Biomedical Engineering or a related field Experience in Quality Management for Medical Devices, including development and/or maintenance of a QMS, as well as participating in internal and external audits Strong knowledge of ISO 13485, MDR, ISO 14971, and standards such as ISO 62304, ISO 62366, Skilled in coordinating processes and providing guidance to colleagues in quality Fluency in German and English   If you're interested in this position, please apply and/or contact Hollie Dear at Adaptive Life Science for more information.

Head of Department – Quality Management & Regulatory Affairs

Aachen
Germany
€90,000 - €100,000 DOE
Head of Department - Quality Management System & Regulatory Affairs Location: Aachen  We are supporting a client in the MedTech industry, specializing in the development and manufacturing of innovative medical devices, in their search for a Head of Quality Management System & Regulatory Affairs. In this role, you will lead a dynamic team, overseeing quality management and regulatory processes to ensure compliance and drive continuous improvement. Key Responsibilities: Lead an interdisciplinary team of experts, fostering a culture of continuous improvement and quality. Manage the company’s Quality Management System (QMS) in compliance with international standards (ISO 13485, EU MDR, FDA), and ensure regulatory approvals for medical devices in global markets. Oversee risk management strategies and ensure the successful planning, execution, and follow-up of internal/external audits and inspections. Collaborate with cross-functional teams in product development, production, and marketing to ensure smooth product launches. Monitor trends in regulatory standards and integrate them into the company's strategic planning. Improve operational efficiency through the integration of automated software systems, enhancing transparency and regulatory compliance. Your Profile: Degree in medical technology, engineering, natural sciences, or a related field. Several years of experience in quality management and regulatory affairs within the medical device industry. Strong knowledge of ISO 13485, EU MDR, and FDA regulations. Proven leadership skills with experience managing and developing teams. Exceptional organizational, communication, and project management skills. Fluency in German and English (both written and spoken) is essential. This position offers the opportunity to lead a key department within a cutting-edge MedTech company, with a focus on driving innovation while maintaining the highest regulatory standards. Who Are Adaptive Life Science? Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally. We are connected with the most innovative medical companies in the world and are ready to support your career development with them. Why Apply With Us? Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including: Expert advice on your CV and cover letter Guidance on salary expectations Personalized interview preparation Connections to exclusive job opportunities Assistance in negotiating the best possible offers 50% of the CVs we send to clients are accepted Accepted or declined, either way we will provide you with feedback We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs. Who Do Adaptive Work With? We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence. If you are interested in this role, please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry. dominika.wyrwinska@adaptivelifescience.com #LI-DW1

Software Validation Engineer

Limburg
Germany
€60,000 - €70,000 DOE
Are you open to a new challenge in Software Validation?   Would you like to be part of a leading team who are pioneers in the medical diagnostic field?   We're currently supporting our client in their search for a new team member in Software Validation! Could this be you?   Key Responsibilities: Plan, execute, and document validation and verification tests for software solutions Develop and maintain validation plans, test plans, and comprehensive reports Analyze and evaluate test results, and implement corrective actions where needed Collaborate closely with development and quality assurance teams to uphold high standards of software quality Assist in preparing risk assessments and technical documentation Create and implement automated testing procedures to enhance the efficiency of validation processes Train and support colleagues on validation-related topics   Requirements: A degree in Biomedical Engineering, Computer Science, IT, or a related field At least 3 years of experience in software validation or quality assurance, preferably in the medical technology field Deep knowledge of testing methods, tools, and relevant standards and regulations Experience with automated test frameworks and scripting languages (e.g., Python) Fluency in German and English   If you're interested in this position, please apply and/or contact Hollie Dear at Adaptive Life Science for more information.

Senior Quality & Regulatory Affairs Manager

Munich
Germany
Circa €70,000 DOE
Senior Quality and Regulatory Affairs Manager Our client is seeking an experienced and motivated Senior Quality and Regulatory Affairs Manager to join their fast-growing medical device company in Munich, Germany. In this role, you will play a crucial part in maintaining global quality and regulatory compliance. You'll have the opportunity to collaborate with internal teams, mentor junior staff, and manage important relationships with regulatory authorities and external partners. Key Responsibilities: Manage and maintain technical documentation for product submissions, changes, and quality management (QM)-related documents. Mentor and train staff across various departments to ensure effective execution of regulatory responsibilities. Conduct compliance audits, including assessments of vendors, clients, and subcontractors. Support and manage external audits with notified bodies and competent authorities, overseeing risk management and post-market surveillance activities. Oversee the establishment, maintenance, and optimization of Quality Systems to ensure full regulatory compliance.. Act as a primary contact for regulatory agencies, assisting with negotiations and managing interactions during inspections and audits. Key Qualifications: Bachelor’s degree in Engineering, Biomedical Sciences, or a related field (Master’s degree or MBA preferred). Minimum of 4 years of experience in quality management and regulatory affairs within the medical device industry. Proven experience with regulatory submissions and approvals such as MDD/MDR. Experience with regulatory audits and a deep understanding of medical device standards. Flexible, goal-driven, and a collaborative team player focused on delivering results. This role offers a unique opportunity to contribute to a growing company and shape the development of cutting-edge medical technologies aimed at improving patient care. Who Are Adaptive Life Science? Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally. We are connected with the most innovative medical companies in the world and are ready to support your career development with them. Why Apply With Us? Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including: Expert advice on your CV and cover letter Guidance on salary expectations Personalized interview preparation Connections to exclusive job opportunities Assistance in negotiating the best possible offers 50% of the CVs we send to clients are accepted Accepted or declined, either way we will provide you with feedback We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs. Who Do Adaptive Work With? We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence. If you are interested in this role, please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry. dominika.wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Hybrid

QMB Quality Management Representative

Freiburg im Breisgau
Germany
€60,000 - €70,000 DOE
QMB Job Description QMB For Medical Device Manufacturer in Freiburg, Germany In this role, you will oversee Quality and Regulatory processes within the company, and ensure suppliers meet relevant requirements Are you a passionate, forward-thinking RAQM professional looking to grow in your career? Are you motivated by quick and efficient decision making processes and enjoy a hands-on, independent working style? Apply now to join my client, a growing, ambitious medical device manufacturer specialising in physiotherapy! Role Incentives Company health management plan Competitive Salary A premium brand with a lot of growth potential Company Culture A young, social and highly motivated team Cooperative management style, short and quick decision-making processes Your Key Responsibilities Maintenance and development of QMS per ISO 13485 and MDR External supplier auditing and certification Risk Management and Incident reporting Other Responsibilities Employee training on Quality and Regulatory matters PRRC Auditing Requirements Fluent German & English (required) Knowledge of and experience working with ISO 13485, MDD or MDR (required) Experience with risk management, root cause analysis and CAPA management for medical (required) Qualifications or experience in medical device Quality Management as a QMB, PRRC or auditor (nice to have) Who Are Adaptive Life Science? Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.   We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.   Why Apply With Us? Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:   Expert advice on your CV and cover letter Guidance on salary expectations Personalized interview preparation Connections to exclusive job opportunities Assistance in negotiating the best possible offers 50% of the CVs we send to clients are accepted Accepted or declined, either way we will provide you with feedback We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs.   Who Do Adaptive Work With? We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.   If you are interested in this role, please apply with your CV or contact Vivien Urban for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.   Vivien.urban@adaptivelifescience.com +49 30 16639819  #LI-VU1  

Head of Global Regulatory Affairs

Berlin
Germany
70,000EUR - 80,000EUR
Head of Global Regulatory Affairs   Are you an experienced Regulatory Affairs professional who is passionate about utilizing AI to make a global impact in healthcare? Our Berlin-based client, an innovator in AI-driven diagnostic solutions, is currently looking for a Global Head of Regulatory Affairs. This role offers home office flexibility and the chance to lead a global team as they expand into international markets, including the US. You would oversee compliance, lead two employees, coordinate teams in India and Egypt, and support market access initiatives.   Your tasks:  Design and monitor processes according to ISO 13485 Lead the regulatory development of certified, AI-based medical devices Expand their software to new international markets, including the USA Oversee risk management in accordance with ISO 14971 Support the product team throughout the product lifecycle, and liaise with government agencies to uphold safety and effectiveness. Collaborate on data protection and IT security issues. Your Profile Experience with ISO 13485 for medical devices, preferably in SaMD. Knowledge of MDR, IEC 62304, ISO 14971, etc. +5 years of experience in Regulatory Affairs within medical technology Strong sense of responsibility and organization Excellent communication skills in English and German What is offered: A dynamic, results-oriented work environment with flexible office/home options. Opportunities for skill development through conferences, workshops, and seminars. Regular team events to enhance corporate culture and solidarity. If you're ready to pioneer the future of AI in healthcare, apply now! If you have any questions regarding the position, please contact: Dominika Wyrwinska at dominika.wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Remote

Read our Blogs

10. 02. 2022

How to bounce back

I want to talk about criticism at work, how to take it, learn from it and move on.It is one of those factors, that un-FORTUNATELY (yes- you read it right) is ever present in our professional lives, and I for one am happy about that.However good we are at our jobs, however efficient and hard-working, there’s always room for improvement.… But how could we improve if we don’t think we need to?Just like Winston Churchill once said:“Criticism may not be agreeable, but it is necessary. It fulfills the same function as pain in the human body. It calls attention to an unhealthy state of things”Even though we all know that constructive criticism is more useful than a praise, I’m sure some of you would agree that being on the receiving end is not always easy.To help, I’ve put together a few tips:First, be open minded. Show your supervisor that you are open to receiving the feedback, why? Managers as well as clients also dislike giving criticism, so by saying that you are open to it, you prove your mental maturity and help to build a better rapport with them for future.Second, listen. Take it all in. Do not feel like you have to respond immediately. You want to show that you have listened, are not defensive and are accountable. Make sure to thank them for the feedback and let them know you appreciate it.Afterwards we might feel bad, embarrassed or even angry. That’s absolutely fine – we’re only human. Call your partner, friend or a close colleague and acknowledge your feelings. Then once you settle down you will start to see the situation in a new light.Third, learn. Try and find a lesson in the criticism given. Now that you had time to digest what’s been said, see what you can take from it for future improvements. 8 out of 10 times, negative feedback is given in order to help you develop and grow.Fourth, move on. Nothing more, nothing less. Once you’ve been given the feedback, you acknowledged your learning or reflected on the mistake – move on.The reason for giving you this feedback in the first place was not to put you down and make you feel incompetent – it is to ensure, that you improve and grow!
10. 06. 2021

How to have a boost in productivity - working from home edition!

Working from home has become the norm for many of us during the pandemic and it looks like it might just be here to stay for a lot us too! It’s great to have the flexibility that comes with working from home, but it’s also a totally different ballgame and something that we need to adapt to as it certainly comes with its challenges. Whether you’re a work from home pro or are still struggling to get accustomed to this new way of life, here are some top tips and reminders to help keep productivity high on a work from home day without compromising your wellbeing: 1.     Try to get into a routine. It can sometimes be tempting to sleep in on a home office day and just roll out of bed and get straight into work, but it’s far more beneficial to get into a routine and have time to mentally prepare yourself for the day ahead. It’s also nice to have some time to yourself before diving into work. Use the time that you would usually spend commuting in a positive way, you could try yoga, meditation or even just spending extra time treating yourself to a lovely breakfast! Did someone say pancakes?2.     Create your designated workspace. Whether you have an office room or not, you should avoid working from your bed or sofa as these should be your spaces for relaxation. Try to create a working space with a desk/table and a comfortable chair and make it YOURS, add items to make it an enjoyable space to be in, this could be your favourite plant or some artwork but try to keep clutter to a minimum because, after all, a tidy space = a tidy mind!3.     Don’t overwhelm yourself. Making a plan for each day can be really valuable and help to give your day some structure but be realistic about the how much you can get done. Make your to-do lists reasonable and be flexible! If you give yourself too many tasks to complete in one day, the thought of even starting the first task can be so daunting that you’ll be more likely to procrastinate and have to rush through your tasks later on. Figure out what works for you for instance, some people like to work to a schedule and adopt time management practices such as the Pomorodo Technique (work for 25 minute intervals, followed by a 5-10 minute break).4.     Take a proper break! When you’re working from home, it can be strangely easy to just keep working through lunch and not step away from your desk for a proper break and change of scenery, but studies have actually shown that taking time away from your desk can directly increase productivity and creativity! Going for a walk or spending time outside is even better for your well-being, soak up that Vitamin D!5.     Hydration, hydration, hydration. Okay, you’ve heard this 100 times before but it never hurts to be reminded. An easy way to ensure that you’re drinking enough water is to buy a time marked water bottle. Fill it up in the morning, set yourself a challenge and make sure that you finish it before the end of the day. You might just notice that your concentration is better, and it will help to keep headaches at bay, particularly when you’re on screens all day!6.     Limit distractions. Of course, we can’t always control everything but do try to control what you can. If you have a particularly demanding project or are under time constraints, you could try removing distractions; let friends/family know not to disturb you, close the door, put your phone on airplane mode or in another room and switch off that TV!7.     Try a productivity tool/app. Utilising productivity tools can be the extra push that you need; they give you incentives and motivate you and there are so many to choose from! Try an app such as Forest, where you plant a virtual tree that takes, for example, ten minutes to grow, and if you can stay off your phone long enough, the tree will finish growing and be added to your on-screen forest, but if you return to your phone too fast, the tree withers and dies. It’s a light-hearted way to avoid digital distractions and gives you a sense of satisfaction! What tips do you have to stay productive at home?
07. 04. 2021

How to resign from your job and leave on good terms

Just accepted an offer for your dream job and wondering how best to approach handing in your resignation? Please read on…If you are reading this my guess is that you have just secured a brand-new role, so a huge congratulations are in order – exciting times ahead! Obviously securing a job offer for your dream position is incredibly exciting but, understandably, sometimes that excitement can be overshadowed by the looming prospect of having to break the news to your current employer that you are leaving them.It’s almost never the easiest of tasks to give the news of your departure to your manager but as it’s an unavoidable task on the road to the next step in your career, so here are some tips to make the process as smooth as possible for all parties. Time is of the essence.This is key to you, your current employer, and your future employer. Obviously, your new company will be keen to have you join them as soon as possible and get stuck into your on-boarding process and your current employer will appreciate you giving them the courtesy of as much time as possible to find your replacement. It would always be the “dream” situation if they had sufficient time to find a new colleague who could join whilst you are still there so there could be a hand-over process and whilst this is not always possible, ensuring you’ve given as much notice as possible will keep everyone happy!Counter-offers.This is a tricky one; sometimes when you let your company know that you’re leaving them they are all of a sudden and (often all too late) desperate to show how important you are as an employee and will present a counter-offer to you. This can be tempting as, after all, increased responsibilities or earnings are always exciting but accepting a counter-offer can actually be extremely damaging in the long-term and set you back further in your career. Realistically, you were looking for a new opportunity for a reason and though the immediate prospect of a salary increase or promotion can be attractive, the long-term reality is that you’re likely to be left with regret for not having taken the new opportunity that provided you with what you were missing. Statistically, 80% of candidates who accept a counter-offer from their current employer actually end up leaving within 6 months after realising that their original reasons for looking are still valid and haven’t truly been addressed. As unfair as it may be, as soon as your company know you were interviewing elsewhere, a level of trust is often lost and your employer may be suspicious that you are interviewing again whenever you are off work. Lastly, it can also damage your relationship with the other company if you accept an offer and then retract it, putting you in a disadvantaged position if you want to work with them in the future.Honesty is the best policy.It can be tempting, and may seem like the easiest option, when asked why you’re leaving to simply say something generic along the lines of “I loved it here but just wanted a fresh challenge” and in some cases this might be true, but often there is a bigger reason behind closed doors. In reality, you are doing your employer a disservice to not share your honest reasons behind your motivation to leave as it can actually help the company to realise areas where they’re potentially not doing so well and their short-comings and how they can better support and retain staff in future. Think about what made you look elsewhere, was it down to the renumeration, lack of training or perhaps there are a lack of opportunities to advance your career? Respectfully and constructively sharing these insights with employers can really help them to improve. That said, be sure to also share everything you have gained from your time there and thank them for the opportunity that they gave to you, which leads me onto my next point...Always be professional.Sometimes it can be tempting once you have already secured a new role to let your professionalism go slightly out of the window, particularly if your reason for leaving is down to a negative relationship or unfair treatment in the workplace. This is never a good idea, namely because you never truly know who knows another professional in the industry, negative information could be passed on and come back to bite you in your career down the line so do not burn bridges and always remain professional as it puts you in the best position.Get excited!Once the task of handing in your resignation is complete, make sure you give yourself some time to celebrate your imminent new chapter! When times are “normal”, it is always a great idea to attend any social functions that you may be invited to with your new employer so you can begin to integrate with the team and get to know your new colleagues. That way, the first day will not be so daunting and there will already be a few familiar faces!I hope these tips help in some way to make the process of moving onto the next step in your career as smooth as possible. Most of all, it’s important that you don’t feel anxious or guilty about resigning – always prioritize your happiness, job satisfaction and personal/professional development above all!