Quality Officer

You will support the Quality function in maintaining and improving the Quality Management System (QMS), ensuring ongoing compliance with GDP standards, ISO requirements, and client expectations. This is a key role focused on driving quality administration efficiency, supporting audits, and promoting a strong compliance culture across internal teams and suppliers.

Location: East Midlands (occasional travel to Birmingham)
Working Hours: 40 hours per week, Monday to Friday

You will support the Quality function in maintaining and improving the Quality Management System (QMS), ensuring ongoing compliance with GDP standards, ISO requirements, and client expectations. This is a key role focused on driving quality administration efficiency, supporting audits, and promoting a strong compliance culture across internal teams and suppliers.

• Provide QA support to internal departments to ensure activities are carried out in line with GDP standards and company procedures
• Offer guidance and advice to operational teams to support compliance and best practice
• Manage and maintain change controls, deviations, and CAPA records, ensuring timely completion and effectiveness
• Support the scheduling and coordination of supplier audits, internal audits, and annual reviews
• Collate and analyse data for reports, investigations, KPIs, and quality metrics
• Assist in the self-inspection audit programme and support QA management activities
• Prepare documentation and support client audits and regulatory inspections, ensuring audit readiness
• Support supplier management activities, including verification, audit actions, and performance monitoring
• Contribute to the ongoing development and compliance of the QMS in line with GDP, ISO 9001, and ISO 13485
• Build strong working relationships with internal and external stakeholders to support QMS activities and compliance initiatives
• Support client onboarding processes, including validation, SAP testing, and process walkthroughs
• Assist with global quality reporting, including KPI submission to the wider QA function
• Support product quality, complaints, and investigation processes
• Review inbound documentation, returns paperwork, and temperature monitoring data, ensuring compliance with ALCOA principles and archiving standards

You will be highly organised, detail-oriented, and comfortable managing a varied workload. Strong communication skills are essential, along with the ability to build relationships across different levels of the business.

You will ideally have experience in:

• Quality administration, including document control, mailbox management, and audit scheduling
• Supporting QMS activities such as investigations, CAPAs, change controls, and audit readiness
• Working with GDP standards, ISO 9001, and ISO 13485 (or similar regulated environments)
• Using systems such as SAP, electronic QMS platforms, and temperature monitoring tools
• Microsoft Office applications (Excel, Word, Visio, etc.)

Previous experience in healthcare, pharmaceuticals, or medical devices is advantageous but not essential.

• 25 days annual leave plus 8 bank holidays, with the option to purchase up to 5 additional days
• Pension scheme
• Life assurance (4x salary)
• Employee Assistance Programme
• Employee discount scheme

Robert Walters Operations Limited is an employment business and employment agency and welcomes applications from all candidates