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 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  

Senior Vigilance and PMS Specialist

Munich
Germany
70,000EUR - 85,000EUR
Senior PMS & Vigilance Specialist Are you a competitive spirit, looking for the next challenge to conquer? Do you believe that effective teamwork can propel you further than you could ever go by yourself? Are you looking for a future-proof workplace where personal and appreciative cooperation is at the core of your employer’s mission? Look no further… Overview: My client is an industry leader in orthopaedic product development and medical education. They are dedicated to delivering top-quality solutions for healthcare professionals and the countless patients benefiting from their devices. Tasks: Creation and submission of vigilance reports in the EMEA region Assessment of potentially reportable incidents Processing product complaints, monitoring and coordinating further processes Handling FSCAs Participating in internal and external audits Your Profile: Degree in a scientific, medical or technical field or comparable qualification Experience working with medical devices or similarly regulated products Sound knowledge of handling customer complaints and reportable events per MDR Knowledge of additional international medical device regulatory frameworks are a plus! (e.g. FDA, MDSAP etc.) Fluent written and spoken German and English are a must! Interested?  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  

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

Production & Supply Chain Manager

Dresden
Germany
70,000EUR - 90,000EUR
Production & Supply Chain Manager (m/w/d) Salary: €70,000 - €90,000 DOE Location: Dresden, Saxony, Germany (Hybrid) Our client is an innovative MedTech startup. They are setting new standards in this field with their products, which are characterized by unique technology, electronics, software, and artificial intelligence. Their products are used directly by end customers/patients and they realize production and logistics through a partner network. For their team in Dresden, they are looking for a Production & Supply Chain Manager Tasks: Support in the transfer of development results to production Participation in the selection of our manufacturing and logistics partners Independent support of the manufacturing partners Optimizing manufacturing and logistics processes with manufacturing partners in terms of quality and costs Ensuring delivery capability in accordance with sales planning Participating in the definition of service processes and returns processing with the partners involved Your Profile: Sound technical training and practical experience in the field of electrical engineering/electronics/mechatronics and/or corresponding technical or industrial engineering studies Approx. 5 years of professional experience in the production area with independent implementation of production control in compliance with cost and quality specifications Strong teamwork and communication skills Willingness and ability to create (in the start-up sector) Open to new approaches Knowledge of the medical technology sector is an advantage Sound knowledge of English. Benefits: An exciting and varied working environment in a dynamic and agile team Creative freedom in an agile start-up environment with a pioneering high-tech medical product Flexible trust-based working hours and the option to work remotely A permanent full-time contract with remuneration in line with the market Professional and personal development opportunities For more information or to apply, please reach out to luke.fines@adaptivelifescience.com with a copy of your CV or alternatively call +49 30 1663 4514  

Project Manager for Medical Device Development

Schwerin
Germany
65,000EUR - 75,000EUR
Project Manager for Medical Device Development Are you an engineering professional with project management expertise and a desire to innovate in a dynamic work environment? Our client located in northern part of Germany is currently seeking a Project Manager to lead the development of respiratory devices, ensuring structured processes, collaboration, and adherence to international standards. Tasks: Leadership in project management for medical device development Execution of all phases in a defined and structured development process Active participation in risk management following ISO 14971 Collaboration with external development partners and customers Co-responsibility for product design, comprehensive testing, validation, and compliance with CE regulations and harmonized standards Preparation of technical documentation for international approvals What is required: Degree in engineering or equivalent In-depth technical understanding Previous experience working within Project Management in MedTech.  Proficiency in both written and spoken German and English What is offered: Flexible working hours and potential for remote work Engaging tasks in growing company and development opportunities Dynamic work environment with creative freedom Annual holiday entitlement of 30 days Attractive social benefits 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  

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  

Quality Specialist

Tuttlingen
Germany
€50,000
Quality Specialist Overview With roots dating back to 1930s, our client is dedicated to specializing in high-quality endoscopy products. With them, you can enjoy the personal benefits of creative freedom, collaboration within a collegial team, and the security of our international group structure as well as experience innovation, access tailored training for professional and personal growth, and work in modern, ergonomic spaces with additional perks. Would you like to elevate your career by expanding expertise in quality management, supplier quality and technical documentation, engaging with a diverse product portfolio? This is your chance! Tasks Maintain and further develop the quality management system in accordance to ISO 13485 Support and participate in internal and external audits (e.g. certifications) Ensure compliance with applicable industry regulations and requirements as well as legal norms and guidelines Maintain work instructions and procedural Take an active role in the creation and maintenance of technical documentation Represent the company externally during audits to prospective suppliers, partners or regulatory authorities Your profile Apprenticeship or vocational training as an industrial clerk, complemented by additional training and interest in technology and medical products or equivalent Experience in MedTech industry and in areas such as Quality Management, Audits and Technical Documentation Solid foundational knowledge of relevant regulatory and normative requirements (MDD, MDR, ISO 13485 etc.) Team player who can also work independently 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  

Read our Blogs

23. 09. 2021

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. 2021

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
10. 06. 2021

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

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