Brightwater Capital, LLC Dublin, County Dublin, Ireland
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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
* 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.
* Team Management: Lead, inspire, and develop the Quality Engineering Team, fostering collaboration, delegation, and performance excellence through regular reviews and goal-setting.
* Continuous Improvement: Partner with production teams to drive continuous improvement initiatives using Six Sigma methodologies.
* System Oversight: Manage key quality system elements, including non-conformance processes, incident reporting, and customer complaint analysis.
* Quality Control: Oversee the activities of the Quality Control group, ensuring seamless integration and high performance.
* Drive Change: Lead key improvements in quality assurance and control systems, championing innovation and operational excellence.
* Collaborate Externally: Build strong relationships with external customers, ensuring their needs and expectations are met.
* Regulatory Excellence: Ensure timely and compliant completion of CAPAs, maintain high-quality documentation, and prepare for audits with confidence.
* GMP Compliance: Provide oversight and ensure GMP standards are consistently met in production and quality engineering activities.
Experience/Requirements
* A third-level qualification in Engineering or a Science discipline is required; a postgraduate qualification in a related area is a plus.
* 5+ years in an ISO 9001/2000 or ISO 13485 environment, ideally in Medical Devices or the Pharmaceutical industry.
* At least 3 years of supervisory experience with a proven track record of team development.
* Experience preparing technical documentation and managing CAPA systems.
* Familiarity with Statistical Process Control and Six Sigma methodologies (Greenbelt Certification is a bonus).
* Knowledge of FDA requirements and experience managing FDA audits.
* Experience with process validation, sterilization, and clean room environments is advantageous.
* Strong interpersonal and communication abilities.
* Exceptional problem-solving and analytical skills.
* 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
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Management and Manufacturing
Industries
* Strategic Management Services
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