Quality Assurance Coordinator

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 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:

To ensure components, materials, and finished products meet defined quality, regulatory, and customer requirements through effective quality control and compliance activities.

To support and maintain the FMP Quality Management System in line with applicable standards and promote product conformity, Good Manufacturing Practices (GMP), and continuous improvement across the organisation.

Benefits:

• 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:

• Carry out activities within the area of responsibility effectively and efficiently to support the achievement of FMP and CliniMed Group objectives.
• Identify and report deviations from established standards, implementing appropriate corrective and preventive actions where required.
• Take proactive actions to achieve operational objectives and key performance indicators (KPIs).
• Manage the correlation, traceability, verification, completion, and distribution of customer-required documentation for batch release, including test certificates, sterilisation certificates, concessions, MFS changes, non-conformance documentation, and other associated records.
• Monitor supplier quality performance and resolve quality issues through effective root cause analysis and implementation of corrective actions.
• Prepare, maintain, and update Standard Operating Procedures (SOPs), work instructions, quality records, and test methods within the eQMS system.
• Conduct internal and supplier audits, analyse findings, and implement quality improvement initiatives to ensure compliance with ISO 13485 standards, identify process improvements, and support supplier qualification and approval activities.
• Host and support ISO 13485 audits conducted by certification bodies and customers by ensuring all required documentation, records, and evidence are prepared and presented effectively, coordinating responses to audit findings, and supporting completion of corrective actions.
• Review, evaluate, and approve customer specification documents, internal manufacturing specifications, and product drawings as part of Product Change Release (PCR) processes.
• Review and assess concessions to ensure out-of-specification materials remain functionally suitable and compliant with applicable regulatory and quality requirements.
• Support investigations, corrective and preventive actions (CAPA), and wider quality improvement projects.
• Maintain awareness of industry best practices and actively contribute to continuous personal development to support an effective Quality Management System aligned with ISO 13485 requirements.
• Collaborate closely with operations teams, senior leadership, managers, production personnel, and suppliers to align quality objectives and drive continuous improvement initiatives.
• Promote and embed a culture of quality, compliance, and operational excellence across the organisation.