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Job Description
Senior Technician, Quality Assurance
Expert QA support to Operations, ensuring operational goals and objectives are achieved for the plant.
Key Responsibilities:
- Provide expert QA support to Operations, ensuring operational goals and objectives are achieved for the plant.
- Be a Subject Matter Expert with regard to Acceptable Quality Standards for products and processes.
- Ensure Regulatory compliance in area to c GMP's of all medical device regulatory agencies.
- Represent QA as the first point of contact for daily line support issues.
- Troubleshoot product and process related issues and identifies root cause.
- Work with QE's and product teams to identify areas for risk reduction and error proofing processes.
- Drive awareness training with PTMs with the assistance of the manufacturing trainer.
- Provide input into the disposition for any non-conforming product and identify appropriate corrective action.
- Perform internal quality audits.
- Trending and analysis of key Quality metrics.
- Assist in the preparation of periodic reports.
Qualifications:
- Level 6 qualification in related quality discipline.
- Minimum of 2 years' experience in a QA role.
- Knowledge of GMP regulated environment and experience in a similar role would be an advantage.
- Can manage obstacles and ambiguity.
- Experience/training in problem solving methodology.
- Builds strong relationships by fostering open communications, respect and trust.
- Is diplomatic, tactful and leverages excellent interpersonal skills to help achieve outcomes.
- Analytical & problem-solving skills, process improvement orientation, and the ability to handle multiple tasks in a fast-paced, results-oriented environment.
- Builds strong customer engagement and credibility by delivering on expectations and commitments.