Quality Analyst

  • Location

  • Salary

  • Job Type

  • Functions

    Device EngineeringQuality Assurance

Company – Global MedTech group – breast cancer diagnosis & treatment

Location – Berlin

About – We’re partnering a major global medical device/diagnostics company, on a position with their Berlin-based subsidiary which develops advanced solutions for their breast & skeletal health portfolio.

They have an opportunity for a Quality Analyst to join their experienced RA/QA team and gain great experience with a range of exciting medical products in a number of different international markets.

The Quality Analyst will take on broad ranging responsibilities for Quality Assurance and be a leader in handling customer complaints.


  • Process and evaluate customer complaints (including statistical evaluation) and implement necessary actions, e.g. blocking batches.
  • Process and evaluate product deviations in incoming inspections, including any special releases or blockings.
  • Work closely with suppliers to analyze problems and develop solutions together.
  • Monitoring and administrative support for the restricted warehouse.
  • Product release.
  • Take part in maintaining and improving the Quality Management system according to ISO 13485 / 21 CFR 820
  • Create and maintain QM documentation, revising documents as appropriate.
  • Provide of training related to QM documents and applicable regulatory requirements to colleagues in the broader company.
  • Initiate, process and follow-up corrective and preventive actions (CAPAs).
  • Prepare Certificates of Analysis.
  • Function as PRRC deputy – person responsible for regulatory compliance in accordance with Medical Device Regulation 2017/745 Article 15 regarding:
  • Ensuring the conformity of the devices is checked appropriately, in accordance with the QMS under which the devices are manufactured, before release
  • Reporting requirements under Articles 87 to 91
  • Deputy for the Quality Management Representative


  • Prior professional experience in a heavily regulated environment – the medical device / IVD fields are strongly preferred.
  • Good knowledge of applicable standards and regulations (ISO 13485, 21 CFR 820, MDR 2017/745, MDD).
  • Strong German and English language skills.
  • Category B driver’s license advantageous.
  • Willingness to travel (5%-10%) mostly within the Greater Berlin Metropolitan area.

Why apply?

This is a fantastic opportunity to join a close-knit team, with flat hierarchies and great development opportunities, within a leading international medical device group.

Please submit your CV to us for a private and confidential discussion about the opportunity.

Apply for this job
Apply now
I consent to storing and processing my personal data as outlined on the 'How Scienta Search Limited manages and uses your personal data' page.

Want to talk?
Get in touch

    Prefer a phone call?

    London: +44 1892 234 050

    Boston: +1 646 603 0850

    Switzerland: +41 41 562 01 59