Senior Technician, Quality Assurance role requires expertise in QA support, regulatory compliance, and process improvement.
Key responsibilities include:
- Providing expert QA support to Operations to achieve operational goals and objectives.
- Ensuring regulatory compliance with cGMP's of medical device regulatory agencies.
- Representing QA as the first point of contact for daily line support issues.
- Troubleshooting product and process related issues and identifying root cause.
- Working with QE's and product teams to identify areas for risk reduction and error proofing processes.
- Driving awareness training with PTMs and assisting with the implementation of error proofing processes.
- Providing input into the disposition for non-conforming product and identifying corrective action.
- Performing internal quality audits and trending analysis of key Quality metrics.
- Assisting in the preparation of periodic reports.
Qualifications:
- Level 6 qualification in a related quality discipline.
- Minimum of 2 years' experience in a QA role.
- Knowledge of GMP regulated environment and experience in a similar role.
- Ability to manage obstacles and ambiguity.
- Experience/training in problem solving methodology.
- Strong analytical and problem-solving skills, process improvement orientation, and ability to handle multiple tasks.