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 Manager - Central Europe

Heidelberg
Germany
€85,000 - €90,000 DOE
Qualitätsmanager Zentraleuropa Überblick Mein Kunde ist ein weltweit führender Anbieter für die Entwicklung, Herstellung und Verbreitung innovativer Mobilitätsgeräte und Lösungen. Mit Geschäftsaktivitäten in 18 Ländern und Produkten, die in über 130 Ländern verfügbar sind, hat sich das Unternehmen auf manuelle und elektrische Rollstühle, pädiatrische Mobilitätsgeräte, Hilfsmittel für das tägliche Leben und mehr spezialisiert. Aufgaben Qualitätsmanagement am Standort, einschließlich der Leitung des Teams und der Prozesse. Enge Zusammenarbeit mit den Direktoren für Regulatory Affairs und Qualitätsmanagement bei Beschwerden und Untersuchungen von Fehlern, um die Ursache und dauerhafte Korrekturmaßnahmen zu bestimmen. Unterstützung und Mitwirkung bei der Analyse von Feldausfällen und Produktionsfehlern, um Produkt und Prozesse zu verbessern. Förderung und Pflege einer Kultur kontinuierlicher Verbesserung, einschließlich Fertigungs- und Konstruktionsprozesse sowie Dokumentationen im gesamten Unternehmen. Sicherstellung der Einhaltung der Produkt-Risikomanagement-Dokumentation gemäß ISO 14971. Unterstützung des Beschaffungsteams bei der Entwicklung und Aufrechterhaltung der Lieferantenqualität, einschließlich der Pflege von Prozessen. Profil Master- oder Bachelor-Abschluss in Ingenieurwissenschaften mit mehreren Jahren praktischer Erfahrung im Qualätsmanagement oder ähnlichen Tätigkeiten in einer Fertigungsumgebung. Umfangreiche Erfahrung in der Umsetzung kontinuierlicher Verbesserungen in einer schlanken Fertigungsumgebung. Erfahrung in der Leitung/Überwachung von Qualitäts-Technikern und Ingenieuren. Ausgezeichnete organisatorische Fähigkeiten, einschließlich der Fähigkeit, Lieferergebnisse und Zeitpläne für die Umsetzung zur Erreichung von Projektzielen zu verwalten. Bereitschaft und Fähigkeit zu nationalen und internationalen Reisen, falls erforderlich. Ausgezeichnete schriftliche und mündliche Kommunikationsfähigkeiten in Deutsch und Englisch. Bewerben Sie sich bitte mit Ihrem Lebenslauf oder setzen Sie sich mit May-Lynn Capocciama-Knecht für weitere Details zu dieser Gelegenheit und zusätzlichen Stellenangeboten im Bereich Forschung und Entwicklung, Regulatory Affairs und Qualitätsmanagement in Verbindung. may-lynn.ck@adaptivelifescience.com +49 30 1663 7750 #LI-MC2

eQMS Systems Manager

Heidelberg
Germany
€85,000 - €95,000 DOE
eQMS Manager Überblick Mein Kunde ist ein weltweit führender Anbieter für die Entwicklung, Herstellung und Verbreitung innovativer Mobilitätsgeräte und Lösungen. Mit Geschäftsaktivitäten in 18 Ländern und Produkten, die in über 130 Ländern verfügbar sind, hat sich das Unternehmen auf manuelle und elektrische Rollstühle, pädiatrische Mobilitätsgeräte, Hilfsmittel für das tägliche Leben und mehr spezialisiert. Unser Kunde sucht derzeit einen erfahrenen eQMS-Systemmanager zur Verwaltung der Implementierung, Optimierung und kontinuierlichen Verbesserung des eQMS im gesamten Unternehmen. Aufgaben Lebenszyklusmanagement der Qualitätsmanagementssoftware, einschließlich Installationen und Konfiguration sowie Entwicklung neuer Workflows für Tests und Validierung. Schulung von Benutzern und lokalen Systemadministratoren sowie Verwaltung von Zugriffen und Rechten für Benutzer. Enge Zusammenarbeit mit dem Softwareanbieter zur Lösung von Problemen bei deren Auftreten, Aktualisierung oder Implementierung zusätzlicher Funktionen im System. Entwicklung von Berichten basierend auf den Anforderungen der Endbenutzer und des Managements, um effiziente Echtzeitberichterstattung zu ermöglichen. Enge Zusammenarbeit mit RA & Qualität, um die Einhaltung der aktuellen Standards und Vorschriften sicherzustellen. Profil Master- oder Bachelor-Abschluss in Ingenieurwissenschaften mit Erfahrung in der Systemadministration. Vorherige Erfahrung mit MasterControl im Bereich MedTech oder einem ähnlichen Bereich ist wünschenswert. Kenntnisse der HTML-Sprache wären von Vorteil. Verständnis der branchenspezifischen Anforderungen und Trends zur Sicherung der Datenintegrität, einschließlich der FDA-Leitlinien für die Industrie zu "Datenintegrität und Einhaltung der cGMP". Erfahrung und Fähigkeiten im Projektmanagement sowie starke Problemlösungsfähigkeiten. Ausgezeichnete Kommunikationsfähigkeiten und Aufmerksamkeit für Details. Bewerben Sie sich bitte mit Ihrem Lebenslauf oder setzen Sie sich mit May-Lynn Capocciama-Knecht für weitere Details zu dieser Gelegenheit und zusätzlichen Stellenangeboten im Bereich Forschung und Entwicklung, Regulatory Affairs und Qualitätsmanagement in Verbindung. may-lynn.ck@adaptivelifescience.com +49 30 1663 7750 #LI-MC2  

Risk Manager

Bielefeld
Germany
€60,000 - €70,000 DOE
Risk Manager Location: Minden, North Rhine-Westphalia, Germany Salary: Circa €60,000 - €70,000 DOE Overview: Our Client are committed to revolutionizing cardio-vascular patient treatment with cutting-edge Class III devices and software solutions. They foster a culture of collaboration, creativity, and a deep-seated commitment to harnessing the latest technology to transform the healthcare landscape. Their diverse team, consisting of software developers, engineers, and healthcare professionals, excels in creating state-of-the-art medical devices and software. Benefits:  •    A job with bright opportunities: at our company, everything revolves around the development and safety of medical devices for both patients and users •    Embrace teamwork: Open communication, mutual support, and respectful collaboration are integral to our daily work •    Flat hierarchies •    Modern working environment •    Flexible working hours and  •    Remote work options •    Dedicated onboarding and ongoing investment in your professional and personal development •    A secure working environment with great people and exciting challenges Tasks:  •    Communication with notified body, competent authority •    Reliable handling of current standards (MDR 2017/745, ISO 14971) •    Perform risk assessment by analyzing current risks and identifying potential risks •    Collaborate with internal and external auditors in conducting policy and compliance audits •    Provide support and training to staff to build risk awareness amongst your team members •    Maintain records of insurance policies and claims •    Negotiate all modifications to Quality Assurance Agreement Your Profile: •    Completed scientific or technical studies •    Several years of experience in the development of medical devices, ideally coupled with practical medical experience for class III devices •    Good technical understanding of systems, and experience in the areas of risk management and safety analyses (FMEA, FTA, PHA) •    Analytical, systematic way of working, strong communication skills and willingness to take responsibility •    Clear communication internally as well as to external partners, customers and notified bodies •    Confident German and English (spoken/written) To apply or for more information please contact Luke via email on: luke.fines@adaptivelifescience.com #LI-Hybrid #LI-LF1  

Risk Manager

Stuttgart
Germany
€70,000 - €90,000
Risk Manager Are you an experienced risk management professional and looking for your next challenge? We are supporting our client in Stuttgart in their search for a new team member who will help to drive the Risk Management activities and impact the successful innovation of life-enhancing medical devices in the cardiovascular field! Focuses: Overseeing risk management activities (focusing on the product development phase) Creation, execution, and evaluation of risk-minimization strategies Creation and maintenance of the risk management file Handling cross-functional team and external stakeholder communication Supporting internal training in risk management Experience required: A degree in medical technology, engineering or comparable 3+ years of experience in the medical technology field Good knowledge of risk management according to ISO 14971 Knowledge of medical device requirements and regulations e.g. ISO 13485, MDR, 21 CFR 820 Strong communication skills Fluency in English and German If you're interested in this position, please contact Hollie Dear for further details: hollie.dear@adaptivelifescience.com #LI-HB1  #LI-Hybrid

RAQM Engineer

Nuremberg
Germany
60,000EUR - 80,000EUR
Regulatory Quality Engineer Join a world-leading company in MedTech, who are working in the field of cancer detection & treatment, as they search for a new team member to support the Quality & Regulatory Affairs activities. You will join a strong team, have varied and interesting projects, and support with the following tasks: Responsibilities: • Coordinating, executing, and endorsing international regulatory product clearances and registrations  • Compiling documentation and approval dossiers for new items while keeping in mind applicable laws and guidelines • Assisting development teams in making sure pertinent standards are followed • Assist with engineering and service teams in all quality-related matters • Assist with process and product enhancements • Upkeep and future advancement of the QM system • You have a great deal of freedom to reshape the environment, become involved in new areas, alter processes, and bring new approaches Experience required: A degree in the medical or scientific field (or equivalent) 3-5 years of experience in Regulatory Affairs and/or Quality Management in the medical technology field Ideally, you bring experience with active medical devices or medical software Fluency in English and German Knowledge of regulatory requirements and medical device relevant standards (e.g. ISO 13485, EU-MDR, ISO 14971) If you're interested in this position, please apply here and/or contact Hollie Dear for further details: hollie.dear@adaptivelifescience.com #LI-HB1  #LI-Hybrid

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!