Quality Management Lead

Vor 3 Tagen

Hamburg, Hamburg, Deutschland elemed Vollzeit

### Opportunity Overview

Elemed, a rapidly growing class III implantable medical device company, is seeking an experienced Quality Management Lead to join their team. This 12-month freelance role offers the chance to define and lead quality initiatives at a pivotal time.

### Key Responsibilities

* Lead and mentor the Quality Management team, driving daily operations and fostering a collaborative culture.
* Implement innovative processes to enhance the 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.
* ~ Ideally working in a manufacturing facility
* ~ Fluency in German and English and ability to work on-site a minimum of 3 days per week

### 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

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