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 activities
Requirements: . 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 Operations
This position is open to all candidates.