Quality Engineer

Location: Darmstadt, Germany (Hybrid – 2 days home office per week after probation)

Salary: Up to €60,000 DOE

Overview:

This opportunity is with a well-established Class III medical implant specialist who has a presence in more than 80 countries globally.

Benefits:

• A varied and challenging role in a modern, growth-oriented company with a leading market position
• Respectful and solution-oriented communication with extremely flat hierarchies and short decision-making processes
• A safe and attractive workplace
• Company pension scheme
• Corporate Benefits: a benefit portal with attractive discounts
• givve Card: a voucher card recharged monthly
• Birthday and company anniversary bonuses for 5, 10, 15, and 20 years of service
• Comprehensive and systematic training
• Summer festival
• Individual training and development opportunities
• Flexible working hours and mobile working (home office)
• 30-days vacation

Tasks:

• Supervise aspects of production and quality assurance
• Direct and implement quality standards (e.g., ISO 13485, internal standards)
• Manage document management systems (transitioning to SAP)
• Support process improvement and compliance
• Optimise and further develop quality management and production processes
• Plan, implement, and monitor procedures and processes for quality assurance across development, production, and quality control
• Create and update quality-relevant documents (procedures, work instructions, specifications, etc.)
• Review conformity and release of finished products
• Implement and monitor CAPA (Corrective and Preventive Actions), deviation, and change control processes
• Plan and execute qualification and validation of quality-relevant systems and processes
• Prepare for, accompany, and follow up on external audits (e.g., by notified bodies, authorities, customers)
• Collect and analyse process indicators/statistics, including production monitoring and regular reporting
• Coordinate and lead projects to improve quality and compliance

Your Profile:

• Successfully completed studies, ideally with a scientific background or in medical technology
• 2–4 years in quality engineering in the medical device industry
• Knowledge of ISO 13485 and regulatory requirements for medical devices
• Experience with document management systems and process optimisation
• Strong organisational and communication skills
• Fluent German and English language skills

For more information, please contact Luke Fines: [email protected] / +49 30 1663 4514

Who Are Adaptive Life Science?

Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.

We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.

Why Apply With Us?

Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:

• Expert advice on your CV and cover letter
• Guidance on salary expectations
• Personalized interview preparation
• Connections to exclusive job opportunities
• Assistance in negotiating the best possible offers
• 50% of the CVs we send to clients are accepted
• Accepted or declined, either way we will provide you with feedback

We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs.

Who Do Adaptive Work With?

We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.

If you are interested in this role, please apply with your CV or contact Luke Fines for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.