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.
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.