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Reports To: Associate Manager/Manager, Quality Assurance
Contract: 12 Month Contract
Shift: Evening Shift. 3.00 pm - 11.00 pm (Some Flexibility).
Key Areas of Responsibility
To 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 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 awareness training with PTMs 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.
* Assist in the preparation of periodic reports
* All other duties as assigned.
Qualifications Knowledge Skills
* 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. (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.
Travel Percentage: None
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