Quality Manager

The Quality Officer is responsible for managing and maintaining the Quality Management System (QMS) in compliance with ISO 13485 / ISO 9001 and other applicable UK and international regulatory requirements. This role ensures the effectiveness and continuous improvement of quality processes, supporting the organization’s commitment to product safety and regulatory compliance. The company manufactures medical devices through third-party manufacturers, requiring close collaboration with external partners to ensure adherence to quality and regulatory standards.

Principal Duties and Responsibilities:

• Oversee and maintain the ISO 13485 and ISO 9001 - compliant Quality Management Systems (QMS), ensuring it aligns with UK MDR 2002, EU MDR, and MHRA requirements.
• Manage compliance with relevant regulatory bodies, including the MHRA, UKCA, and CE marking requirements.
• Lead and coordinate internal and external audits, including third-party manufacturer audits, supplier audits, and regulatory inspections.
• Maintain and communicate quality policies, procedures, and work instructions to maintain compliance and efficiency.
• Monitor and manage third-party manufacturers' compliance with ISO 13485, Good Distribution Practices (GDP), and regulatory requirements.
• Oversee non-conformance reports (NCRs), corrective and preventive actions (CAPAs), and root cause analysis investigations, including those related to third-party manufacturers.
• Conduct risk management activities, including Failure Mode and Effects Analysis (FMEA), process validation, and supplier risk assessments.
• Monitor and analyse supplier and third-party manufacturer quality metrics to identify trends and opportunities for improvement.
• Provide training and guidance to employees and external partners on quality standards, regulatory requirements, and best practices.
• Maintain accurate and organized documentation related to quality processes, audits, supplier management, and regulatory submissions.
• Support supplier quality management, including supplier audits, evaluations, and corrective actions.
• Stay updated with changes in UK and international regulations to ensure ongoing compliance.

Requirements:

• Strong understanding of ISO 13485, UK MDR 2002, EU MDR, MHRA, UKCA, and CE marking requirements.
• Experience with third-party manufacturer oversight, audits, CAPA processes, risk management, and supplier quality management.
• Knowledge of document control systems and QMS software.
• Strong problem-solving skills with experience in root cause analysis and process improvement.
• Excellent communication skills and ability to work effectively with cross-functional teams and external partners.
• Certification in auditing (e.g., Lead Auditor ISO 13485) is a plus.

Desirable Qualifications:

• Bachelor’s degree in engineering, Life Sciences, or a related field.  Preferred but not essential.
• 3-5 years of experience in quality management, preferably in the UK medical device industry under ISO 13485.
• Auditor Certified (e.g., ISO9001, ISO13485)
• Experience of regulatory body liaison e.g., the HSA (Ireland), HSE (UK), Environmental Agency, Local Authorities.

Desired Characteristics

• Pro-active, self-starter.
• Flexible and adaptable to changing environments.
• Attention to detail and strong analytical skills
• Ability to manage multiple tasks and meet deadlines
• Strong leadership and decision-making skills
• Proactive approach to problem-solving and process improvements
• Ability to work independently and collaboratively within a team and with external partners
• Flexibility to travel

• This role provides an excellent opportunity to contribute to the organization's commitment to quality and regulatory excellence, ensuring compliance with ISO 13485, UK MDR 2002, and third-party manufacturing quality standards to enhance overall product safety and efficiency.