Supplier Quality Engineer

Adaptive Business Group; München; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

Join a leading company in the medical device industry as a Supplier Quality Engineer in Munich. You will play a vital role in ensuring robust processes and high-quality outcomes while collaborating across departments. Bring your experience in project management and quality systems to contribute to life-saving technologies.

Leistungen

Opportunities for personal and professional development

Work in a cross-functional, international environment

Qualifikationen

• Several years of experience in the medical device industry.
• Deep understanding of ISO 13485 and FDA regulations.
• Strong knowledge of manufacturing processes.

Aufgaben

• Lead process validations for internal and supplier manufacturing.
• Develop risk-based validation strategies.
• Maintain the Quality Management System.

Kenntnisse

Project Management

Quality Management Systems

Risk Management

Analytical Skills

Communication

Ausbildung

Degree in Engineering, Life Sciences

Jobbeschreibung

Are you an experienced Quality, Supplier, or Process Validation Engineer looking to make a meaningful impact in the medical device industry?

Would you like to shape the future of life-saving implantable technologies in a collaborative and fast-paced environment?

Join our client’s growing Operations and Quality team and play a critical role in ensuring robust processes and high-quality outcomes across internal and external manufacturing.

Key Responsibilities :

• Lead the planning and execution of process validations (IQ, OQ, PQ) for both internal and supplier-based manufacturing processes.
• Develop efficient, risk-based validation strategies that balance quality, compliance, and business timelines.
• Support and challenge external supplier validations and ensure alignment with internal standards and regulatory expectations.
• Maintain and improve the Quality Management System in line with ISO 13485 and FDA regulations.
• Lead or contribute to supplier development activities during the design transfer phase, ensuring suppliers meet quality, technical, and timeline requirements.
• Drive continuous improvement in supplier quality, process capability, and risk mitigation.
• Collaborate cross-functionally with R&D, Regulatory Affairs, and Manufacturing to support product industrialization.
• Serve as a project lead on validation and supplier-related initiatives, managing external partners with appropriate oversight and escalation.

Requirements :

• Degree in Engineering, Life Sciences, or a related technical field.
• Several years of experience in the medical device industry, ideally in Supplier Engineering, Process Validation, Quality Engineering, or Project Management roles.
• Deep understanding of quality management systems (QMS) and regulatory requirements (ISO 13485, FDA 21 CFR Part 820).
• Strong knowledge of manufacturing processes (e.g., injection moulding, machining, extrusion) and validation principles.
• Proven ability to lead projects and work effectively with external partners and suppliers.
• Risk-based mindset with excellent documentation and analytical skills.
• Strong communication skills in English; German is a plus.

What’s in it for you?

• Join a purpose-driven company focused on breakthrough implantable devices.
• Work in a cross-functional, international environment where your input directly impacts patient lives.
• Enjoy diverse challenges across quality, operations, and supplier development.
• Be part of a high-growth organization with opportunities for personal and professional development.

If you’re passionate about ensuring quality and process excellence in the medical device space, apply now and / or contact Hollie Dear at Adaptive Life Science for more information!

Supplier Quality Engineer • Munich, Bavaria, Germany