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. 09. 2023

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
25. 02. 2023

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). 
01. 02. 2023

Sustainability in the Medical Device Industry

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.