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. 05. 2024

Relocate For Medical Device Jobs – why it can come with benefits and growth when it’s done right

Relocation and its benefits are a huge topic within recruitment, especially when speaking about niche industries like: MedTech, Aviation and Aerospace, or Mining.
23. 09. 2023

5 tips to get more out of your working day

5 tips to get more out of your working day Do you ever get the feeling that there are simply not enough hours in a day to get everything done? That feeling when you make your morning coffee, barely manage to get your admin under control, and somehow its 3pm already. Worry no more – we are here to help!Here are 5 tips to help you become a little bit more productive, work smarter (without longer hours) to get more value out of your working day...Step 1. PrioritiseEach morning, take a few minutes to go through the list of tasks set for the day, then try and evaluate their priority. These should be based on the urgency of the said task, time they might take, but also on how challenging or complex they may be. Start with the toughest, most time consuming first.Step 2. Time blockMake sure you set yourself time for each task and try and stick to it. I’m not going to lie, this does require some discipline, but trust me – it pays off. When setting time blocks be realistic and don’t overcommit - If you think a particular task will take minimum of an hour to complete, don’t block less than that, as you end up putting yourself under unnecessary pressure and by rushing, you run the risk of making mistakes. Oh, and I almost forgot, make sure to block some time for a little ‘’you time’         Step 3. is just as important: Breathe and take a breakIt is important to remember that breaks play a vital part in the building of an efficient working mind set. Walk away from your computer, grab some fresh air, socialise with your colleagues, or do anything else that you enjoy, that does not involve checking your email every 3 minutes or eating your sandwich by your desk. Recharge your batteries, so that when you return to working you are near a full tank and you have all the energy and brain space needed to finish the day with consistent momentum. Step 4. Complete what you startedThis ties in quite well with blocking your time and is just as important. If you start something, make sure to finish it before moving on to the next task. Focus on one thing at a time. Break down bigger projects into time blocks, especially if its ongoing or overwhelming at the start. Step 5. Remove distractionsSome tasks require laser focus, so turn off your email, shut down your Teams, turn your phone on Airplane mode, and let your co-workers know that you will be unavailable. According to a study by Microsoft researchers, it takes the brain 15 minutes to re-focus after switching our attention to something else. So if you’re constantly being interrupted, it’s going to take you a long time to get your work done. What tips would you recommend to get more value out of your working day?
09. 09. 2023

Signs it's time to look for a new job

How do you know when it’s time to look for a new job?If you’ve clicked on this article, that might be the first sign… maybe your subconscious is trying to tell you something? It’s understandable, everyone has bad days, weeks, even months at work and we all sometimes face burnout, but when you can’t remember the last time you felt happy or fulfilled at work, it might just be time to change that!You often think about a new jobIt might sound obvious, but many people overlook having these thoughts, even when it’s on a regular basis. If the prospect of a new job feels exciting to you or even brings a wave of relief, perhaps it’s time to stop ignoring that and trust your gut. Do you find yourself scrolling through job adverts on the weekend or stopping to check what a recruiter has shared? It might be time to take action to at least know what’s out there.Your work-life is eating into your personal lifeHave you started to realise that even when you’re at home, all you can think about is work? Perhaps you’re always irritable and have even taken out work-related stress on a friend or family member? Or you just can’t remember when you had the time or energy to enjoy life outside of the office? Maybe you need to start considering an opportunity that offers more flexibility and a better work/life balance – believe it or not, they’re out there!Lack of development and resources Do you struggle to remember the last time your company invested in training and development initiatives? You’ve even tried to voice your concerns, and nothing has changed? Situations like these can make it hard to see a future at a company and impossible to envision achieving growth in your career. Perhaps it’s time to start polishing that CV! There’s surely a company out there who will offer you the well-deserved support and growth opportunities that you’re missing now.Got the Monday blues?Of course, no-one really wants the weekend to end but if you find yourself spending the majority of Sunday dreading the thought of Monday morning, that’s a clear sign that you’re not happy and a red flag that you need to look out for your well-being too!Lack of motivationCan’t remember that passion and enthusiasm that you had when you first started? If you’re struggling to find motivation, and even feeling like you’ve lost your sense of purpose at work, it might be sign that you’re not feeling challenged enough and you need something more mentally stimulating to keep things interesting!You’re underpaidMany different factors come into play when it comes to salary and it’s not a clear-cut conversation, but if you’re an asset to your company, clearly delivering your objectives (even surpassing them) and you never see any indications of progression in terms of salary, it’s not surprising that this can lead to feeling undervalued and demotivated. Toxic workplace relationshipsPeople are different, so it’s expected that we cannot be best friends with everyone in the workplace. However, when you notice problematic relationships at work are having an impact on you, you’re likely not in the best environment to excel, both professionally and personally. If you find yourself feeling lost in a new workplace culture (and you can’t make it better), it might be time to consider a fresh opportunity.Are some of these points sounding all too familiar? No need to panic!Now is the time to start the process of making a change for the better, and although it can seem daunting it should be exciting too! Maybe you could start by updating your CV or connecting with a trusted head-hunter in your industry who could support you on your way to the next step in your career.“Our finest moments are most likely to occur when we are feeling deeply uncomfortable, unhappy, or unfulfilled. For it is only in such moments, propelled by our discomfort, that we are likely to step out of our ruts and start searching for different ways or truer answers.” — M. Scott Peck