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Quality Manager
Industry specialist
Niall Finnerty
Recruitment Consultant
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Job Summary:The Quality Manager will be responsible for ensuring compliance with all relevant medical device regulations and quality standards, including ISO 13485 and FDA requirements. This role involves overseeing quality assurance processes, leading audits, and driving continuous improvement initiatives to enhance product quality and regulatory compliance.
Key Responsibilities:
Key Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 and FDA regulations.
- Lead internal and external audits, including regulatory inspections and supplier audits.
- Oversee product quality and compliance throughout the manufacturing process.
- Manage CAPA (Corrective and Preventive Actions) and non-conformance investigations.
- Provide leadership and training to the quality team and production staff on quality best practices.
- Collaborate with cross-functional teams to ensure quality objectives are met.
- Drive continuous improvement initiatives to enhance product quality and reduce defects.
- Ensure proper documentation and record-keeping in compliance with regulatory requirements.
- Act as the primary point of contact for regulatory bodies and notified bodies.
- Bachelor’s degree in Engineering, Quality Management, or related field.
- 5+ years of experience in a quality management role within a medical device or regulated manufacturing environment.
- Strong knowledge of ISO 13485, FDA regulations, and GMP requirements.
- Experience in managing audits, CAPA processes, and risk management.
- Excellent leadership, problem-solving, and decision-making skills.
- Strong communication and interpersonal skills.
- Six Sigma or Lean Manufacturing certification.
- Experience with regulatory submissions and compliance documentation.
- Familiarity with validation and process improvement methodologies.
- Office and manufacturing floor-based work.
- Occasional travel for audits and supplier visits may be required.