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 Assurance Specialist

Mainz
Germany
€50,000 - €65,000 DOE
Quality Assurance Specialist Our client, a leading developer and manufacturer in the medical device industry based near Mainz is seeking to strengthen their team with a Quality Assurance Specialist. This role is critical in ensuring the highest standards of quality and compliance for innovative medical solutions. Responsibilities: Manage CAPAs, conduct risk and root cause analyses, perform effectiveness checks, and coordinate corrective measures. Oversee the process of controlling defective products. Assist in both internal and external audits. Monitor updates in standards, laws, and guidelines, and coordinate evaluations with relevant stakeholders. Implement training programs on quality management, hygiene, and regulatory requirements. Create and edit SOPs, and act as a contact person for quality management within the company. Requirements: Completed medical or scientific studies or comparable training. Relevant experience in quality or regulatory management within the medical device sector. Proficiency in quality and regulatory requirements (ISO 13485, MDSAP, 21 CFR 820, EU MDR). Fluency in both German and English language. Strong commitment, initiative, and sense of duty. Effective time management and systematic analytical skills with experience in MS Office. What is offered: Opportunities for process improvement with independent work. A friendly atmosphere and colleagues who value mutual respect. Part of a successful team in an innovative family business with short decision-making processes. Professional and personal development through internal and external training. Active health support to ensure you have the right work-life balance. Hybrid working style. Company events, free parking, and more. Does it sound interesting? Join our client's dynamic team and contribute to the development and manufacturing of top-tier medical solutions! If you have any questions regarding the position, please contact:  Dominika Wyrwinska at dominika.wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Hybrid  

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

Head of Quality/Regulatory

Mainz
Germany
€120,000 - €170,000
Head of Quality and Regulatory Affairs Are you passionate about Quality Management and Regulatory Affairs? Are you a hands-on leader, with expertise in managing RAQM processes in the diagnostics field? Are you looking for a role where you can have the freedom to really drive change and make a difference for your team? Apply now to join my client, a leading international diagnostics company, as their new Head of Quality and Regulatory Affairs! Ready to put your skills to work? Your Tasks: Maintain QMS and ensure compliance with applicable quality & regulatory requirements Provide leadership, guidance, and mentoring to Quality and Regulatory teams Identify and implement initiatives to enhance the quality system and drive efficiencies Timely resolution of non-conformances and complaints Budget & Stakeholder Management incl. communication with Notified Bodies Your profile:   Master or higher degree in science or a related field Min. 10 years’ experience in quality assurance and control, preferably in the medical device or diagnostic industry. Extensive knowledge of ISO13485, FDA 21 CFR 820, IVDR/MDR Demonstrated ability to drive change, implement best practices, and achieve results. Fluent German and English Please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. vivien.urban@adaptivelifescience.com +49 30 16639819 #LI-VU1  

Risk Manager

Munich
Germany
65,000EUR - 75,000EUR
Are you interested in joining a dynamic company who are innovating in the cardiovascular field? Would you like to have a major impact on the successful market delivery of medical devices and transform treatment options for patients? We're currently supporting a client in the medical device industry who are headquartered in Munich and are looking to strengthen their team. Responsibilities: Initiate, maintain, and update the risk management process in compliance with ISO 14971, 21 CFR820, and other relevant standards. Develop, maintain, and update all documents within the risk management file, including risk management plans, FMEAs, annual reports, and more. Coordinate and oversee all risk management activities with cross-functional teams.. Contribute to the assessment of customer feedback and risk evaluation, analysing quality issues, complaints, incidents, and proposed changes related to known and potential new risks. Prepare all risk-related documents for the technical file, such as risk-benefit analyses. Support and plan product Design Verification and Validation activities. Requirements and Skills: Bachelor’s degree in Engineering or a related field. 3+ years of experience in risk management of medical devices in accordance with ISO 14971, ideally for class II or III devices. Proficiency in technical, regulatory, and medical writing, with experience in drafting technical reports.  Fluency in English, German is a bonus. Experience working with regulatory bodies and competent authorities. Basic understanding of regulatory requirements for medical devices, particularly MDR and 21 CFR820. If you're interested in this position, please apply here and/or contact Hollie Dear at Adaptive Life Science for more information. #LI-HB1  #LI-Hybrid  

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  

Field Service Engineer Wuerzburg

Wuerzburg
Germany
Flexible, depending on experience
Field Service Engineer Our esteemed client, a leading provider in the healthcare industry is currently seeking a talented individual to support clients in the Würzburg area. As part of their commitment to revolutionizing oncology solutions, they are currently looking for a dynamic full-time Field Service Engineer. In this role, you will play a pivotal role in ensuring the optimal performance of advanced medical equipment at clinics and private practices. Tasks: Act as the primary point of contact for customers (clinics and private practices) regarding service and repairs Perform upgrades, and procure necessary spare parts, with autonomous assignment planning Establish close communication with clinic and practice staff to identify errors, provide advice, and conduct equipment instruction Utilize software analysis tools to evaluate machine data and generate comprehensive service reports and documentation Requirements: Completed technician training or relevant studies with a technical emphasis (e.g., electrical or medical technology) Preferably, experience in the maintenance and repair of electronic devices Strong interpersonal skills and a dependable work ethic, with a passion for direct customer interaction Willingness to travel regularly in the Würzburg area Fluent in German and English, with a valid driver's license Benefits: 32 days of annual leave Company car provided for both business and personal use Attractive overtime and bonus arrangements Comprehensive company pension scheme Additional travel and accident insurance coverage at home and abroad Flexible working hours, comprising approximately 80% travel within the region and 20% home office Extensive bonuses for exceptional performance, along with subsidies for remote work Fitness club subsidies and the opportunity to lease a JobRad If you are passionate about making a difference in the fight against cancer and possess the skills and dedication required for this role, apply today and become part of a team committed to creating a world without fear of cancer. If you have any questions regarding the position, please contact: Dominika Wyrwinska at dominika.wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Hybrid

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. 2023

Relocation – 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.
01. 02. 2023

Sustainability in MedTech & Life

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.