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

09. 06. 2022

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? 
10. 02. 2022

How to bounce back

I want to talk about criticism at work, how to take it, learn from it and move on.It is one of those factors, that un-FORTUNATELY (yes- you read it right) is ever present in our professional lives, and I for one am happy about that.However good we are at our jobs, however efficient and hard-working, there’s always room for improvement.… But how could we improve if we don’t think we need to?Just like Winston Churchill once said:“Criticism may not be agreeable, but it is necessary. It fulfills the same function as pain in the human body. It calls attention to an unhealthy state of things”Even though we all know that constructive criticism is more useful than a praise, I’m sure some of you would agree that being on the receiving end is not always easy.To help, I’ve put together a few tips:First, be open minded. Show your supervisor that you are open to receiving the feedback, why? Managers as well as clients also dislike giving criticism, so by saying that you are open to it, you prove your mental maturity and help to build a better rapport with them for future.Second, listen. Take it all in. Do not feel like you have to respond immediately. You want to show that you have listened, are not defensive and are accountable. Make sure to thank them for the feedback and let them know you appreciate it.Afterwards we might feel bad, embarrassed or even angry. That’s absolutely fine – we’re only human. Call your partner, friend or a close colleague and acknowledge your feelings. Then once you settle down you will start to see the situation in a new light.Third, learn. Try and find a lesson in the criticism given. Now that you had time to digest what’s been said, see what you can take from it for future improvements. 8 out of 10 times, negative feedback is given in order to help you develop and grow.Fourth, move on. Nothing more, nothing less. Once you’ve been given the feedback, you acknowledged your learning or reflected on the mistake – move on.The reason for giving you this feedback in the first place was not to put you down and make you feel incompetent – it is to ensure, that you improve and grow!
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?