Quality Analyst

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.

Duties

• 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

Experience/Qualifications

• 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.