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Quality Management Lead

vor 2 Monaten

Hamburg, Hamburg, Deutschland elemed Vollzeit
Job Opportunity: Interim Quality Management Lead

About the Role:

We are seeking an experienced Quality Management Lead to join our team at elemed, a rapidly growing class III implantable medical device company. As a key member of our quality team, you will be responsible for leading and mentoring our Quality Management team, driving daily operations, and fostering a collaborative culture.

Key Responsibilities:

  • Implement innovative processes to enhance our Quality Management System (QMS), ensuring seamless integration with global operations.
  • Take charge of critical audits and inspections, correcting deficiencies and elevating standards.
  • Serve as the expert in Quality Management Systems (QMS), providing hands-on support and strategic direction.

Requirements:

  • 8+ years of experience in Quality Management and Quality Control for medical devices.
  • Ideal experience working in a manufacturing facility.
  • Fluency in German and English, with the ability to work on-site a minimum of 3 days per week.

About elemed:

elemed is a unique, collaborative environment where innovation thrives. We are committed to integrating groundbreaking solutions into our international operations and are seeking someone who is passionate about making a tangible difference in the medical device industry.

Key Skills:

ISO 13485, 21 CFR 820, CE marking, MDR, Medical device regulation, MDD, medical devices, Digital health, 510(k), PMA, Regulatory affairs, quality assurance, QA/RA, design quality, ISO 14971, combination devices, sterilisation, AIMDD, CER, PMCF