Work Flexibility: Onsite
Senior Technician, Quality
Reports To: Associate Manager/Manager, Quality Assurance
Contract: 12 Month Contract
Location: Springhill, Carrigtwohill
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 qualification: 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. (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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Travel Percentage: None