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

Quality and Regulatory Manager

Remote
Germany
65,000EUR - 85,000EUR
Regulatory Affairs Specialist Are you an experienced Regulatory Affairs professional interested in Artificial Intelligence? We are currently supporting a client dedicated to advancing patient well-being through innovative AI technologies in radiology. The company operates 100% remotely and is now looking for a Regulatory Affairs Specialist to support their team with outstanding product quality and continuous regulatory compliance, breaking the last barrier before go-to-market. Your tasks: Ensuring product quality and continuous regulatory compliance. Support with market expansion. Report to Chief Medical Officer. Engage in product development by consulting on regulatory matters and managing risks. Shape process landscape and train employees to achieve operational excellence. What is required: Full proficiency in Business English and German. Excellent written and verbal communication skills. Experience with regulatory affairs (MDR and ISO 13485) IT skills and ability to thrive in a dynamic, fully remote environment. Experience in MedTech / SaaS / startup environment is an advantage. If you have any questions or you are interested in other roles within MedTech, please contact Dominika Wyrwinska at  dominika.wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Remote  

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

Quality Control Manager

Leipzig
Germany
€60,000 - €65,000 DOE
Quality Control Manager  Are you passionate about maintaining the highest standards of quality in medical device manufacturing and eager for the next step in your career? Our client, based in Saxony, is currently seeking a Quality Control Manager to join their team. Specializing in regenerative medicine and cutting-edge technology, our client excels in developing innovative products. As their Quality Control Manager, you will play a vital role in ensuring their innovative products meet quality standards.   Responsibilities: Establish quality procedures, standards, and specifications. Collaborate with purchasing manager to ensure raw materials meet quality requirements. Assess company production processes to develop in-house quality policies and procedures. Ensure compliance with local and global production standards. Implement and monitor quality assurance standards. Oversee product-related projects with subcontractors and internal departments and monitor product development processes.  Handle post-process activities such as sterilization, packaging, and shipment. Requirements: Bachelor of Science or similar education with minimum of 2 years of experience. Technical training or studies, ideally in quality or measurement. Analytical thinking and independent working style. Proficient in Q methods and tools, Microsoft 365 (especially Excel). High commitment and willingness to learn. Fluent in German and English with strong communication skills. If this sounds like you, please do not hesitate and send the application. If you have any questions regarding the position, please contact:  Dominika Wyrwinska at dominika.wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Hybrid  

Regulatory Affairs Manager

Tuttlingen
Germany
60,000EUR - 70,000EUR
Regulatory Affairs Officer Overview Are you looking for a new challenge in regulatory affairs? I am currently supporting a client who specializes in sleep diagnostics in southern Germany in hiring an expert in EU MDR, approval processes, IEC 60601, IEC 62304 and ISO 14971. This is a hybrid working position where you can work 2/3 days from home. Tasks Implementation and maintenance of regulatory approval of medical devices in accordance with EU MDR Assisting in the compilation of documentation and supporting in the creation and maintenance of risk management files in accordance with ISO 14971 and usability files in accordance with IEC 62366-1 Support international distributors in the approval process of the medical devices PMS activities such as PMS files and vigilance investigations Your profile Experience in areas such as regulatory affairs or technical documentation in the MedTech or medical device industry Solid foundational knowledge of relevant regulatory and normative requirements (MDD, MDR, ISO 13485 etc.) IT Skills such as MS Office Good communication and organizational skills as well as independence and reliability Fluency in English and German Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. may-lynn.ck@adaptivelifescience.com +49 30 1663 7750 #LI-MC2  

QM/QA Specialist

Stuttgart
Germany
50,000EUR - 60,000EUR
QM/QA Specialist Overview Our client has been developing and manufacturing implants, abutments and other components for suppliers for more than 25 years. Are you a working student or intern graduating this year and wanting to take your first step in Quality Management in the medical device industry? This is your chance! Tasks Maintenance and development of the quality management system in accordance with ISO 13485 Documentation management including risk management FMEA SOPs and trainings Process validation and monitoring Supplier management Complaint handling and CAPA management   Your profile Technical background with experience in Quality Management, Quality Assurance, CAPA or Risk Management in the medical device industry Familiarity with Norms and Standards like ISO 13485 Fluent in German and English Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management. may-lynn.ck@adaptivelifescience.com +49 30 1663 7750 #LI-MC2  

Read our Blogs

19. 06. 2024

Medical Device Conferences 2024 Europe (June - December 2024)

If you have not yet managed to catch a Medical Device Conference in 2024, or you are considering attending more, then this is the list for you! Here at Adaptive Life Sciences, we have selected 6 fantastic Europe-based Medical Device conferences you should attend, including online conferences for those of you who cannot find the time to travel. In order to improve readability, this list is arranged in date order.
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?