Quality Manager / QMB

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    Hollie Dear

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Quality Manager / QMB
Ruhr Region

Our client is one of the leading pioneers in the medical device industry for women’s health and diagnostic technology. They have been a reliable partner for general practitioners and clinicians for almost 20 years when it comes to concept-based conservative patient care.

Their innovative Class Im and IIa products are designed in-house with their R&D team and distributed globally. For their QM department, they are searching for a QMB to oversee the quality strategy, and continue their success in maintaining the ISO13485 certification!

About The Opportunity:

  • Join the company as the QMB, and management responsibility of 1 QM employee.

  • Ownership of the QM strategy, including direct contact with the Notified Body and authorities.

  • Cover topics of QMS maintenance and improvement (according to ISO13485), post-market surveillance, CAPA management and supporting the creation of the CER.

  • Flexible working is possible 2/3 days a week from home.

  • Culture fit for the team: open communication, change driver and hands-on in improving processes.

  • 30 days of vacation, 13th salary split across summer and Christmas.

  • Flat hierarchy, and role reporting directly to CEO level.

  • Sociable team – there has been a table tennis championship, recreation area outside, electric bikes for leasing, sports memberships, and a friendly work environment!

What You Bring:

  • Degree in Biomedical Engineering, or another Life Science discipline.

  • 3+ years of experience in quality management within the medical device industry, working according to ISO13485.

  • Knowledge in risk management and ISO14971 is appreciated to ensure close working with the R&D team during product development.

  • Fluent German and English is required – the QMS documentation is in English.

For more information about this opportunity and others in the Medical Device industry, please reach out to Hollie.Dear@adaptivelifescience.com