QA /RA Engineer.

A growing medical device company is looking for an experienced QA/RA Engineer.The role includes:. CAPA & non-conformities management.

Management

Reviews and Quality KPIs. SOPs, training, and document control.

Design

Quality, Risk Management, and ECOs. Operations and Supplier Quality. Applicable standards and regulatory compliance. Sterilization and shelf-life activitiesRequirements: . B.Sc. in Engineering, Life Sciences, or a related field. 4-5 years of QA/RA experience in the medical device industry.

Practical experience with ISO 13485 and medical device QMS. Knowledge of ISO 14971, EU MDR, and FDA requirements. Excellent written and verbal English skills. Hands-on, independent, proactive, and comfortable working cross--- functionally with R&D and OperationsThis position is open to all candidates.