Senior Quality Assurance Specialist

1 day ago

Carrigtwohill, Cork, Ireland beBeeQuality Full time €45,000 - €60,000
Job Title

Senior Quality Technician - 12 Month Contract

About the Role
  • To be a Subject Matter Expert regarding Acceptable Quality Standards for products and processes.
  • Ensure Regulatory compliance in areas of cGMPs of all medical device regulatory agencies (e.g., FDA).
  • Represent QA as the first point of contact for daily line support issues.
  • Troubleshoot product and process-related issues and identify root causes.
Key Responsibilities
  1. Work with QE's and product teams to identify areas for risk reduction and error-proofing processes, and work on their implementation.
  2. Drive defect awareness training with product builders with the assistance of the manufacturing trainer.
  3. Provide input into the disposition of any non-conforming product and identify appropriate corrective actions with other support team members.
  4. Perform internal quality audits.
  5. Trend and analyze key quality metrics.
  6. Responsible for the timely analysis of customer complaints supporting Divisional and Operational goals and objectives.
  7. Complete investigations and analysis of customer complaints.
  8. Maintain systems for the receipt and recording of customer complaints.
  9. Assist in the preparation of periodic reports.
  10. Maintain biohazard laboratory systems.
  11. Manage obstacles and ambiguity; experience/training in problem-solving methodologies (Engineering Essentials TM).
Requirements
  • NCEA diploma in a related discipline.
  • Minimum of 2 years' experience in a QA role.
  • Knowledge of GMP regulated environments and experience in a similar role is an advantage.
  • Good knowledge of statistics is an advantage.
  • Excellent interpersonal skills to help achieve outcomes.
  • Analytical and problem-solving skills, process improvement orientation, and the ability to handle multiple tasks in a fast-paced, results-oriented environment.

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