Quality Manager

 We are currently seeking an experienced Quality Manager to join a leading medical device manufacturing organisation. This is an excellent opportunity for a quality professional with strong leadership experience and a proven track record in quality systems, regulatory compliance, and continuous improvement within a regulated manufacturing environment.

The successful candidate will be responsible for overseeing all aspects of the Quality Management System (QMS), ensuring compliance with industry standards and regulatory requirements while leading quality initiatives across the business.

Key Responsibilities: 

Quality Management Systems & Compliance

• Act as Management Representative for the Quality Management System (QMS).
• Ensure QMS processes and documentation are established, implemented, maintained, and continuously improved.
• Maintain compliance with ISO 13485, ISO 9001, FDA 21 CFR Part 820, and other applicable regulatory requirements.
• Monitor QMS performance and identify opportunities for improvement.
• Promote quality and regulatory awareness throughout the organisation.
• Lead Management Review activities and ensure compliance with regulatory expectations.
• Oversee document control and quality records management.

Audits & Regulatory Affairs

• Serve as the primary point of contact for external audits conducted by customers, certification bodies, and regulatory authorities.
• Plan, manage, and conduct internal quality audits.
• Ensure effective implementation of corrective actions arising from audit findings.

Quality Operations

• Lead and oversee CAPA, non-conformance management, customer complaints, and quality investigations.
• Ensure timely resolution of quality issues and implementation of effective corrective and preventive actions.
• Support product development, manufacturing, and product release activities.
• Ensure Quality Control operations are effective and aligned with quality objectives.
• Authorise product disposition decisions and escalate quality concerns where necessary.
• Take appropriate action, including stopping production or shipment, to prevent non-conforming products reaching customers.

Supplier Quality Management

• Review, approve, and monitor suppliers of materials, components, products, and services.
• Support supplier qualification, audits, and performance management activities.
• Ensure supplier compliance with quality requirements and standards.

Requirements

Education & Experience

• 5–10 years' experience in Quality Assurance and/or Quality Control within medical device manufacturing or a similarly regulated industry.
• Demonstrated experience managing quality systems and regulatory compliance programs.
• Previous people management and leadership experience.

Technical Knowledge

• ISO 13485
• ISO 9001
• FDA 21 CFR Part 820
• Medical Device regulations and quality standards
• FMEA
• DOE
• SPC
• Statistical analysis techniques
• Experience managing audits, CAPA systems, supplier quality, and complaint handling processes.

Skills & Competencies

• Strong leadership and decision-making abilities.
• Excellent problem-solving and analytical skills.
• Outstanding written and verbal communication skills.
• Ability to influence and collaborate effectively across all levels of an organisation.
• Strong organisational and project management capabilities.
• Willingness to travel as required for supplier visits, audits, and business needs.

For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose