Quality Assurance Director
5 days ago
At Brightwater, we are seeking a Quality Assurance Director to lead our Quality Leadership Team and drive continuous improvement initiatives. Our ideal candidate will have experience in managing quality systems and leading teams to achieve operational excellence.
About the PositionWe are looking for a seasoned professional with 5+ years of experience in ISO 9001/2000 or ISO 13485 environments, preferably in Medical Devices or the Pharmaceutical industry. The successful candidate will be responsible for overseeing key quality system elements, including non-conformance processes, incident reporting, and customer complaint analysis.
Key Responsibilities- Lead the Quality Leadership Team and ensure our quality systems align with ISO standards and regulatory requirements.
- Partner with production teams to drive continuous improvement initiatives using Six Sigma methodologies.
- Manage key quality system elements, including non-conformance processes, incident reporting, and customer complaint analysis.
- Oversee the activities of the Quality Control group, ensuring seamless integration and high performance.
Requirements
- A third-level qualification in Engineering or a Science discipline is required; a postgraduate qualification in a related area is a plus.
- At least 3 years of supervisory experience with a proven track record of team development.
- Familiarity with Statistical Process Control and Six Sigma methodologies (Greenbelt Certification is a bonus).
- Knowledge of FDA requirements and experience managing FDA audits.
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