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

25. 02. 2023

Video Interview Tips and Tricks for Success

As businesses across the globe are forced to transition to a remote and digital workforce, so are interviews.  Zoom, Skype, Teams and other video conferencing tools are becoming today’s interviewing norm.The truth is, whether you’re an interview guru or just jumping back into the job market, technical issues and unexpected trip-ups are now more possible than ever before.  So be prepared. Put yourself in the best situation to ensure you crush your video interview.Below are a handful of tips and tricks gathered from recruiters, hiring managers, candidates and industry professionals to put you in the best position possible:PREPARE YOUR TECHNOLOGY In an ideal, even typical situation, you would be sitting across the table from your recruiter or hiring manager.  However, with today’s circumstances, video conferencing is the next best thing.  With this, comes different video platforms; you should check to see if you need to create an account, download an app, or insert a password.  Additionally, be sure to test your connection prior to the interview.  You don’t want your first impression to be that you were late because you couldn’t figure out the platform.Test your camera and mic – nothing else can start an interview on the wrong foot, than a webcam or mic malfunction.  You don’t want to be the “Can you hear me? Can you hear me now?” interviewee.This one seems simple, but is commonly one that is forgotten…charge your device!  Whether you are taking the interview on your phone or computer, be sure you are sufficiently charged or if possible, plug into a power source.DRESS THE PART You should still dress to impress!  This helps to not only boost confidence, but will also leave a strong first impression.  Plan to wear the same clothes you’d wear if you were meeting in-person…yes this includes pants.  We have all heard the jokes about taking video calls in your underwear, but don’t let that be you.  Most likely, the interviewer(s) will only see your face and shoulders, but you should be prepared.BODY LANGUAGE AND SPEECH Video interviews can be uncomfortable and seem unnatural, but do your best to be yourself and get your personality across.  Be mindful of your posture, remember to nod and be engaged, try not to fidget, and don’t forget to smile!  Gesture with your hands as you normally would and don’t feel restricted or stiff just because you are talking to a computer screen.Do your best to speak clearly and deliberately.  Issues with internet and connection can occur and this can cause delays or sound quality issues.  So be adaptable and do your best to ensure your audience is understanding you.  Try pausing momentarily before responding, as there can be a delay and cause you to talk over one another.Eye contact.  This one can be a bit more challenging depending on your computer/webcam set up, how many interviewers are on the call or how the platform displays the video.  Your impulse is typically to look at the face on the screen or be distracted by yourself.A few helpful tips:Look at the camera as much as you can (this will give the appearance of making eye contact)Place a sticky note over yourself on your screen as to not be distractedPosition your camera at eye-level for the most flattering and straight forward anglePractice! (remember it doesn’t come natural to look at the camera rather than the people on the screen)BE CONSCIOUS OF YOUR ENVIRONMENT Beware of any potential distractions such as family, friends or pets.  Try to ensure you have privacy and won’t be interrupted or distracted.Turn your camera on before your interview and evaluate your background and lighting.  Have a professional, clean and clutter-free background within the frame. And don’t forget to check your lighting, no one wants to join an interview and realize you are so backlit, it looks like you’re taking the call from a dungeon.If the lighting isn’t favorable:Try facing a window to get natural lightSet up a light or two behind the screen to brighten yourself and backgroundIncrease the brightness on your screen to add some illumination to your faceBE ADAPTABLE It’s important to remember that technical issues or distractions can and do happen, even if you prepare.  Things can take place on your end or the interviewers, they are in the same situation as you and working to do what they can to give you the best interview experience.  Be patient and be understanding.DON’T FORGET TO FOLLOW UP This will always be a best practice for any type of interview.  Remember to leave a strong impression and send a thank you note to the interviewer(s). 
01. 02. 2023

Sustainability in the Medical Device Industry

Sustainability is more than a buzzword; it’s a business imperative. The world is facing environmental and social crises and consumers are demanding that companies and individuals take responsibility and action. It’s a hot topic in our work lives as much as it is privately. For many of us, it guides the brands we choose, the food we eat, and the decisions we make in day-to-day life. Fast fashion is one example of unsustainable living and a major contributor to the worldwide problem. Overall, the fashion industry is responsible for 8-10% of global emissions, according to the UN - more than the aviation and shipping combined. The term ‘fast fashion’ describes the quick turnover of fashion trends and the move towards cheap, mass-produced clothing where new lines are constantly released. What is the environmental impact of this? Most of fashion's environmental impact comes from the use of raw materials: ​Cotton for the fashion industry uses about 2.5% of the world's farmlandSynthetic materials like polyester require an estimated 342 million barrels of oil every yearClothes production processes such as dying requires 43 million tonnes of chemicals a year​How does sustainability impact the Medical Device industry? Manufacturers are giving sustainability in medical device design more and more attention. Sustainable medical equipment can benefit businesses in terms of cost savings, investor attraction, greater brand value, and competitive advantage, in addition to being better for the environment and appealing to consumers. Manufacturers must consider sustainability at the beginning of the design phase and take the equipment's whole lifecycle into account if they are to gain these advantages. How to make medical devices more sustainable There are many approaches to make medical devices more sustainable. For example, they could use less energy, be produced with low-emission materials and procedures, utilize fewer materials or less packaging, or have longer lifespans. The sustainability of a medical device is significantly influenced by the choice of materials. Using more sustainable materials makes a device more tolerable for patients, for example by using fewer toxic chemicals during production. Using the fewest resources possible in production helps to enable recycling alternatives. Sustainability considerations should be built into the design of the device from the very beginning. However, medical device manufacturers face several challenges as a result. A lot of devices, such as needles and catheters, must be packaged sterile, which produces a lot of waste. The options for substituting or reducing the materials used is often limited due to the sterility requirements. Other manufacturers can switch to reusable materials or make their packaging as mono-material a possible, which makes it easier to recycle. The first step in becoming more sustainable is having an awareness of it as a business, or as a personal goal. Using this awareness can help us all to make better conscious decisions in our buying patterns, and in our R&D processes.
09. 06. 2022

What can we do that promotes resilience?

Building ResilienceResilience is the capacity to recover quickly from difficulties. So, what can we do that promotes resilience? AcceptanceWe must accept that stress, mistakes, and failure are an inevitable part of our everyday, in our professional work and in our personal lives. Adversity does not discriminate, we all have to handle situations in life of challenging pressures at work, grieving for a loved one, conflict in relationships or mental illness. The list goes on…The saying ‘failure is not an option’ is redundant in today’s emotionally intelligent world. Resilient people know that sh*t happens.In case you were thinking about boxing up all that stress, worry and, pressure - suppression is not an effective strategy. Try not to think about something, and guess where your mind goes… The ability to make mistakes, learn from them, and rebound is resilience building and from this we can branch out into new directions, boost our immune system and lead happier lives. Run Towards Resilience By taking opportunities for change and personal/professional development, we learn how to handle failure, rejection, mistakes; how to rebound and recover from extraordinary circumstances.Build your resilience by making pursuits meaningful. Meditation, photography, learning a new language, taking that course, asking for more responsibility at work…Be kind to yourself by discovering enjoyment in the challenges you face and be optimistic, even on the tough days. By finding your inner drive to take on new projects and also keeping in mind your future focus, you’ll be more autonomous, pragmatic and nurtured as a person.  Stronger and more prepared for whatever comes next in life. Mindset Matters Slow and gradual behaviour change is more likely to last. Commit to a manageable behaviour change and we are more likely to follow-through. Balance this with self-compassion.Exercise is so good for us, not only physically but for our mental health and to build cognition. Aim to do a walk for 10 minutes a day over lunch but always show compassion to yourself. If you are too self-critical when you miss one day, you are less likely to bounce back the next day.Be careful of when you place your attention.  As humans, our survival instinct makes us excellent at noticing weaknesses and threats. Take a step back, is the way you are thinking going to help you, or just have a detrimental impact you?Resilient people make a conscious effort to not be swallowed up by the negative and instead focus on benefit finding, all those things in your life that you can be grateful for.Don’t do it aloneMake a deliberate effort to find what’s good in your life. This should include a strong social connection with colleagues, friends, and family who you can turn to in your times of need. Resilient people ask for help when they need this and see this as a sign of inner-strength, not weakness. What changes do you need to make in your life or your mindset to become resilient?