Ensuring short-term goals and long-term strategy set by the QA leadership team it adhered to.
Provide QA leadership and appropriate support during cross-functional meetings and projects, including the necessary QMS trainings.
Overseeing complaints and customer queries, managing root cause analysis to ensure issues are identified and corrective actions are put in place and executed.
Launch Complaint Investigations and provide effective reports to drive continuous improvement.
Support external audits and organise supplier audits.
Compile and sustain the Technical Documentation.
Requirements
Engineering or relevant Science degree
Minimum 5 years’ experience in RAQA roles within a medical device manufacturer.
Strong knowledge and working experience in ISO 13845 and relevant RA topics (MDR & MDD, knowledge of FDA QSR requirements would be beneficial).
Previous experience with injection moulding is a significant advantage.