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

Risk Manager

Frankfurt
Germany
60,000EUR - 80,000EUR
Risk Manager Location: Frankfurt area (high degree of remote flexibility) Would you like to work for a global leader in the treatment of renal disease and support the safety of the product through a risk management process? We are currently supporting our client who is looking for a Risk Manager to join their Product Development Team. Your tasks: Plan and execute the risk management process. Create risk assessments for complaints and support the preparation of FMEAs. Support the audit of design & development and risk management sessions. Create and monitor the design control metrics in development, post-market activities, and change management. Monitor the state of the art to continuously improve product safety. Responsible for pre-production defect management (Anomaly Reports), risk analysis, and specification of countermeasures. Your profile: A degree in engineering, biology, medical technology, or equivalent. Minimum of 3 years of experience in Regulatory Affairs, Research and Development, or Risk Management. Experienced in medical device regulations (EU MDR, MDSAP, MDD 93/42/EEC, etc.) High degree of knowledge in FMEA method, and quality management and risk management standards (ISO 13485 and ISO 14971). Fluent in written and spoken English and advantage of German skills. Benefits: Very international environment. High home office flexibility and flexible working hours. Continuous support in the development. Pension scheme. Please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in Medical Technology. Dominika.Wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Remote

Read our Blogs

25. 05. 2023

Relocation – why it can come with benefits and growth when it’s done right

Relocation and its benefits are a huge topic within recruitment, especially when speaking about niche industries like: MedTech, Aviation and Aerospace, or Mining.
01. 02. 2023

Sustainability in MedTech & Life

Sustainability is more than a buzzword; it’s a business imperative. The world is facing environmental and social crises and consumers are demanding that companies and individuals take responsibility and action. It’s a hot topic in our work lives as much as it is privately. For many of us, it guides the brands we choose, the food we eat, and the decisions we make in day-to-day life. Fast fashion is one example of unsustainable living and a major contributor to the worldwide problem. Overall, the fashion industry is responsible for 8-10% of global emissions, according to the UN - more than the aviation and shipping combined. The term ‘fast fashion’ describes the quick turnover of fashion trends and the move towards cheap, mass-produced clothing where new lines are constantly released. What is the environmental impact of this? Most of fashion's environmental impact comes from the use of raw materials: ​Cotton for the fashion industry uses about 2.5% of the world's farmlandSynthetic materials like polyester require an estimated 342 million barrels of oil every yearClothes production processes such as dying requires 43 million tonnes of chemicals a year​How does sustainability impact the Medical Device industry? Manufacturers are giving sustainability in medical device design more and more attention. Sustainable medical equipment can benefit businesses in terms of cost savings, investor attraction, greater brand value, and competitive advantage, in addition to being better for the environment and appealing to consumers. Manufacturers must consider sustainability at the beginning of the design phase and take the equipment's whole lifecycle into account if they are to gain these advantages. How to make medical devices more sustainable There are many approaches to make medical devices more sustainable. For example, they could use less energy, be produced with low-emission materials and procedures, utilize fewer materials or less packaging, or have longer lifespans. The sustainability of a medical device is significantly influenced by the choice of materials. Using more sustainable materials makes a device more tolerable for patients, for example by using fewer toxic chemicals during production. Using the fewest resources possible in production helps to enable recycling alternatives. Sustainability considerations should be built into the design of the device from the very beginning. However, medical device manufacturers face several challenges as a result. A lot of devices, such as needles and catheters, must be packaged sterile, which produces a lot of waste. The options for substituting or reducing the materials used is often limited due to the sterility requirements. Other manufacturers can switch to reusable materials or make their packaging as mono-material a possible, which makes it easier to recycle. The first step in becoming more sustainable is having an awareness of it as a business, or as a personal goal. Using this awareness can help us all to make better conscious decisions in our buying patterns, and in our R&D processes.
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!