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

09. 04. 2021

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? 
07. 04. 2021

How to resign from your job and leave on good terms

Just accepted an offer for your dream job and wondering how best to approach handing in your resignation? Please read on…If you are reading this my guess is that you have just secured a brand-new role, so a huge congratulations are in order – exciting times ahead! Obviously securing a job offer for your dream position is incredibly exciting but, understandably, sometimes that excitement can be overshadowed by the looming prospect of having to break the news to your current employer that you are leaving them.It’s almost never the easiest of tasks to give the news of your departure to your manager but as it’s an unavoidable task on the road to the next step in your career, so here are some tips to make the process as smooth as possible for all parties. Time is of the essence.This is key to you, your current employer, and your future employer. Obviously, your new company will be keen to have you join them as soon as possible and get stuck into your on-boarding process and your current employer will appreciate you giving them the courtesy of as much time as possible to find your replacement. It would always be the “dream” situation if they had sufficient time to find a new colleague who could join whilst you are still there so there could be a hand-over process and whilst this is not always possible, ensuring you’ve given as much notice as possible will keep everyone happy!Counter-offers.This is a tricky one; sometimes when you let your company know that you’re leaving them they are all of a sudden and (often all too late) desperate to show how important you are as an employee and will present a counter-offer to you. This can be tempting as, after all, increased responsibilities or earnings are always exciting but accepting a counter-offer can actually be extremely damaging in the long-term and set you back further in your career. Realistically, you were looking for a new opportunity for a reason and though the immediate prospect of a salary increase or promotion can be attractive, the long-term reality is that you’re likely to be left with regret for not having taken the new opportunity that provided you with what you were missing. Statistically, 80% of candidates who accept a counter-offer from their current employer actually end up leaving within 6 months after realising that their original reasons for looking are still valid and haven’t truly been addressed. As unfair as it may be, as soon as your company know you were interviewing elsewhere, a level of trust is often lost and your employer may be suspicious that you are interviewing again whenever you are off work. Lastly, it can also damage your relationship with the other company if you accept an offer and then retract it, putting you in a disadvantaged position if you want to work with them in the future.Honesty is the best policy.It can be tempting, and may seem like the easiest option, when asked why you’re leaving to simply say something generic along the lines of “I loved it here but just wanted a fresh challenge” and in some cases this might be true, but often there is a bigger reason behind closed doors. In reality, you are doing your employer a disservice to not share your honest reasons behind your motivation to leave as it can actually help the company to realise areas where they’re potentially not doing so well and their short-comings and how they can better support and retain staff in future. Think about what made you look elsewhere, was it down to the renumeration, lack of training or perhaps there are a lack of opportunities to advance your career? Respectfully and constructively sharing these insights with employers can really help them to improve. That said, be sure to also share everything you have gained from your time there and thank them for the opportunity that they gave to you, which leads me onto my next point...Always be professional.Sometimes it can be tempting once you have already secured a new role to let your professionalism go slightly out of the window, particularly if your reason for leaving is down to a negative relationship or unfair treatment in the workplace. This is never a good idea, namely because you never truly know who knows another professional in the industry, negative information could be passed on and come back to bite you in your career down the line so do not burn bridges and always remain professional as it puts you in the best position.Get excited!Once the task of handing in your resignation is complete, make sure you give yourself some time to celebrate your imminent new chapter! When times are “normal”, it is always a great idea to attend any social functions that you may be invited to with your new employer so you can begin to integrate with the team and get to know your new colleagues. That way, the first day will not be so daunting and there will already be a few familiar faces!I hope these tips help in some way to make the process of moving onto the next step in your career as smooth as possible. Most of all, it’s important that you don’t feel anxious or guilty about resigning – always prioritize your happiness, job satisfaction and personal/professional development above all! 
25. 02. 2021

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).