Quality Assurance Director Medical Device jobs

About FMP:

Flexible Medical Packaging Limited (FMP) is the part of Clinimed Holding Limited, a group of companies founded in 1982 following the acquisition and formation of number of additional companies within the group.

Flexible Medical Packaging (FMP) Limited are offers a first-class turnkey service of sterile and non-sterile products, for the Healthcare provision. It is our mission to ensure that our customers are completely satisfied with the quality of our work and service. Supported by years of experience and extensive industry knowledge, we are confident in our ability to provide a level of service that will surpass our customers’ expectations.

Job Summary:

The Head of Quality will lead the overall Quality & Regulatory strategy at FMP, ensuring products, processes and systems consistently meet regulatory, customer and internal quality requirements. The role oversees both Quality Assurance (QA) and Regulatory Affairs (RA), maintaining compliance with ISO 13485, MDR, GMP and applicable FDA requirements for Class II and Class III medical devices. You will drive continuous improvement and a Zero Defects culture, while providing strong quality support to Production, strengthening the QMS and ensuring high levels of compliance and customer satisfaction.

Benefits:

• Company Car / Car Allowance
• Contributory Pension Scheme (5% Employer Contribution Raises up to 10% with Service)
• Medical Cash Back Plan (Simply Health)
• Life Assurance (4 x Annual Gross)
• Annual Performance Bonus
• Annual Pay Review
• Work Life Balance
• Employee Referral Scheme
• Free Yearly Flu Vaccination
• Onsite Free Car Parking
• Employee Assistance Programme – Health and Wellbeing
• 25 days per annum rising to 27 after 5 years’ service (plus 8 Bank Holidays and one company day)

Main Duties & Responsibilities:

Regulatory Affairs (RA)

• Provide strategic leadership for all Regulatory Affairs activities at FMP.
• Ensure compliance with applicable global regulatory requirements, including ISO 13485, MDR and relevant FDA standards.
• Maintain regulatory readiness and ensure documentation, processes and systems meet audit and regulatory expectations.
• Act as the key contact for regulatory authorities regarding product and site compliance.
• Oversee regulatory submissions, approvals and ongoing regulatory requirements.
• Ensure regulatory considerations are embedded into business decisions, new product introductions, material changes and customer requirements.
• Monitor regulatory developments and communicate relevant changes to senior leadership.
• Support Group-wide regulatory readiness, harmonisation and continuous improvement initiatives.
• Oversee the completion and maintenance of technical and medical device files, ensuring compliance with MDR requirements.

Quality Assurance (QA)

• Lead the development, maintenance and continuous improvement of the Quality Management System (QMS).
• Oversee internal and external audits, ensuring effective investigation and timely closure of non-conformances (NCRs).
• Ensure robust quality processes covering incoming inspection, supplier quality, product release, validation and verification, calibration, complaints, change control and document control.
• Establish and monitor quality objectives, KPIs and improvement plans to drive measurable performance.
• Promote a Zero Defects culture through effective root cause analysis and problem-solving methodologies, including 8D, DMAIC and Ishikawa.
• Oversee laboratory operations and product release activities.
• Ensure strong alignment between Quality and Production to maintain product consistency, compliance and process capability.
• Develop and manage the Quality department budget, ensuring effective allocation of resources.

Compliance & QMS Governance

• Ensure FMP meets all internal, corporate and external quality and regulatory compliance requirements.
• Develop the long-term strategy for the evolution and continuous improvement of the QMS, benchmarking against regulatory guidance and industry best practice.
• Maintain ongoing readiness for ISO certification, customer and regulatory audits.
• Lead GMP-related improvements and ensure delivery of the GMP maturity roadmap.
• Ensure effective documentation, data integrity and training compliance across the QMS.
• Maintain robust quality risk management processes, including FMEA and risk assessment methodologies.

Leadership & People Development

• Lead, mentor and develop the Quality team, ensuring strong technical capability, regulatory knowledge and operational performance.
• Build a collaborative quality culture across Operations, Engineering, Customer Service and Supply Chain.
• Set clear objectives, manage performance and support the professional development of team members.
• Promote effective cross-functional communication, collaboration and problem-solving.

Production & Operational Support

• Provide proactive quality leadership and support to Production, ensuring process robustness and product conformity.
• Support continuous improvement initiatives to reduce waste, eliminate recurring issues and improve process stability and capability.
• Review and approve sterilisation validation reports, including dose mapping studies.
• Strengthen alignment between Quality and operational functions to support efficient, compliant manufacturing.

Customer & External Stakeholder Engagement

• Lead quality-related communication with customers, including claims management, investigations, follow-up actions and preventive measures.
• Develop strong customer relationships and ensure expectations are clearly understood and effectively addressed.
• Provide Quality and Regulatory support during customer audits, site visits and new product introductions.
• Act as a senior Quality and Regulatory representative with customers and other external stakeholders.

Personal Specifications:

• Degree in Biomedical Engineering, Life Sciences, Quality, or a related discipline.
• Minimum 5 years’ experience in senior Quality and/or Regulatory Affairs roles within the medical device, pharmaceutical or healthcare sector.
• Strong experience managing ISO 13485 Quality Management Systems and regulatory compliance.
• In-depth knowledge and practical experience of MDR and GMP requirements.
• Experience working within an FDA Class II/III medical device environment would be advantageous.
• Proven leadership and people-management experience, with the ability to build and develop high-performing teams.
• Strong understanding of quality risk management, validation and verification processes.
• Excellent leadership, communication and influencing skills, with the ability to work effectively across functions and with senior stakeholders

Ability to commute/relocate:

• Lancaster LA1 4XS: reliably commute or plan to relocate before starting work (required)

Application question(s):

• Will you now or in the future require sponsorship for employment visa status?

Work authorisation:

• United Kingdom (required)

Work Location: In person