Contract: 23 month Fixed term contract Shift work: 24/5 Hours: 7-7 REPORTS TO : ASSOCIATE MANAGER, QUALITY ASSURANCE Position summary: To provide expert QA support to Operations, ensuring operational goals and objectives are achieved for the plant KEY AREAS OF RESPONSIBILITY: 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 as assigned.
QUALIFICATIONS KNOWLEDGE SKILLS Minimum qualification: Level 6 qualification in related quality discipline.
Minimum of 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.
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