Quality Operations Manager

3 days ago

Dublin, Dublin City, Ireland Brightwater Capital, LLC Full time

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

Please contact on or simply click the apply button. To view all live jobs with Brightwater and market insights, please visit our website:

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