Quality Operations Manager
About the Company
My client is a leading multinational medical device company, specialising in innovative solutions that improve quality of life.
About the Position
My client is seeking a Quality Operations Manager to join their team in a critical leadership role, where you’ll be at the heart of our mission to maintain the highest standards of quality, compliance, and continuous improvement.
Key Responsibilities
1. Quality Leadership: Be a key member of the Quality Leadership Team and the site’s extended leadership team, ensuring our quality systems align with ISO standards and regulatory requirements.
2. Team Management: Lead, inspire, and develop the Quality Engineering Team, fostering collaboration, delegation, and performance excellence through regular reviews and goal-setting.
3. Continuous Improvement: Partner with production teams to drive continuous improvement initiatives using Six Sigma methodologies.
4. System Oversight: Manage key quality system elements, including non-conformance processes, incident reporting, and customer complaint analysis.
5. Quality Control: Oversee the activities of the Quality Control group, ensuring seamless integration and high performance.
6. Drive Change: Lead key improvements in quality assurance and control systems, championing innovation and operational excellence.
7. Collaborate Externally: Build strong relationships with external customers, ensuring their needs and expectations are met.
8. Regulatory Excellence: Ensure timely and compliant completion of CAPAs, maintain high-quality documentation, and prepare for audits with confidence.
9. GMP Compliance: Provide oversight and ensure GMP standards are consistently met in production and quality engineering activities.
Experience/Requirements
1. A third-level qualification in Engineering or a Science discipline is required; a postgraduate qualification in a related area is a plus.
2. 5+ years in an ISO 9001/2000 or ISO 13485 environment, ideally in Medical Devices or the Pharmaceutical industry.
3. At least 3 years of supervisory experience with a proven track record of team development.
4. Experience preparing technical documentation and managing CAPA systems.
5. Familiarity with Statistical Process Control and Six Sigma methodologies (Greenbelt Certification is a bonus).
6. Knowledge of FDA requirements and experience managing FDA audits.
7. Experience with process validation, sterilization, and clean room environments is advantageous.
8. Strong interpersonal and communication abilities.
9. Exceptional problem-solving and analytical skills.
10. High-level computer literacy and the ability to work effectively in cross-functional teams.
Remuneration Package
A competitive package is available including generous salary and benefits.
Contact
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