Contract: 23 month Fixed term contract
Shift work: 24/5
Hours: 7-7
Location: Tullagreen, Carrigtwohill
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 identify 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.
* All other duties as assigned.
QUALIFICATIONS KNOWLEDGE SKILLS
* Minimum qualification: Level 5/ Leaving Cert or equivalent.
* Minimum of 2 years’ experience.
* 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.
* Builds strong relationships by fostering open communications, respect and trust.
* 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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