Senior Quality Manager

  • Location

    Munich, Germany

  • Sector:

    Quality Assurance

  • Salary:

    €60-85,000 dependent on experience

  • Contact:

    Martin Larkin

  • Job ref:

    18059

  • Published:

    about 1 year ago

  • Expiry date:

    2019-10-22

Senior Quality Manager

We are looking to recruit an experienced Quality Manager to join the Quality Management & Regulatory Affairs team at a client of ours in Munich. Our client is delivering patient care through their digital mobile app with well over 1million users across Europe.

Quality Role:

+ Ensure measures are in place to allow a high level of consistency of all regulatory processes

+ Maintain an agile approach while ensuring all medical device related processes comply to ISO13485 and other Quality standards

+ Manage and refine the ISO 13485 compliant QMS & RMS

+ Implement internal improvement processes including internal audits, CAPA or non-conformity management

Your Experience:

+ Experienced working within a QM role within the medical device space, with a strong understanding of the latest EU and FDA regulations

+ Experienced with ISO standards for Quality - IEC 62304, AAMI TIR45, and risk management - ISO14971

+ Work experience within a 'software as a medical device' environment would be an advantage

+ Experienced optimizing existing processes and authoring lean process descriptions that align with the business

For an initial conversation about this opportunity please apply below or email directly to martin.larkin@adaptivelifescience.com and we will be in touch to discuss your suitability.