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- Be a Subject Matter Expert with regard to Acceptable Quality Standards for products and processes.
- Ensure Regulatory compliance in area to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV)
- 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 and work on implementation of these.
- Drive Defect awareness training with product builders with the assistance of the manufacturing trainer.
- MRB: Provide input into the disposition for any non-conforming product and identify appropriate corrective action with other support team members.
- Perform internal quality audits.
- Trending and analysis of key Quality metrics.
- Responsible for the timely analysis of customer complaints to acceptable Quality Standards supporting Divisional and Operational goals and objectives.
- Complete investigation and analysis of customer complaints.
- Maintain systems for the receipt and recording of customer complaints
- Assist in the preparation of periodic reports
- Maintain biohazard laboratory
- Maintain systems for Customer complaints
- All other duties assigned
- NCEA diploma in related discipline.
- Ideally 2 - 3 years’ experience in a QA role.
- Knowledge of GMP regulated environment and experience in a similar role would be an advantage.
- Good knowledge of statistics would also be an advantage.
- Can manage around obstacles and ambiguity. Experience/training in problem solving methodology. (Engineering Essentials TM)
- 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.
For further Information on this role, please contact John on 021 4911065 or email firstname.lastname@example.org
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