Quality Engineering Specialist

About the role

Join CooperVision’s Quality team in Hamble and help ensure new contact lens products meet the highest quality standards. Reporting to the Quality Engineering Manager, you will drive compliance with the Quality Management System (QMS) and lead continuous‑improvement projects across UK manufacturing sites.

Key responsibilities

• Participate in new product and process introduction projects, ensuring QMS requirements are met.
• Plan and execute process validation activities, preparing validation plans, protocols and reports.
• Support risk management using FMEA and guide teams on risk‑based decision making.
• Assess and manage engineering change orders (ECO) as the designated change assessor for the UKM.
• Analyse production data, monitor process capability, and lead problem‑solving projects to improve quality.
• Maintain audit‑ready status by ensuring compliance with FDA, MDR and other regulations.
• Assist CAPA and NCR investigations as needed.

Required profile

• Experience in a manufacturing or medical‑device environment.
• Strong understanding of QMS, validation, risk management and change control.
• Ability to work collaboratively with production, engineering and support teams.

Required skills

• Process Validation
• FMEA (Failure Mode and Effects Analysis)
• Engineering Change Management (ECO)
• Data Analysis and Process Capability assessment
• Quality Management System (QMS) compliance
• Regulatory knowledge (FDA, MDR)

What we offer

• Competitive salary and benefits package.
• Opportunity to work on innovative contact lens technologies.
• Professional development and training in quality engineering.