Quality Engineer

Company: CooperSurgical
Apply for the Quality Engineer
Location: Fareham
Job Description:

Overview

In this role you will support Delta Park Distribution Operations by applying quality systems and data analysis to improve outgoing quality. You will contribute to process validation, risk management and change management within the Packaging and Distribution Quality Engineering Team, based in Fareham with occasional travel to nearby sites. You will work cross-functionally to ensure compliance and drive quality improvements across the distribution network. This is a hands-on, impact-focused role in a global, quality-driven company with a clear mission to enhance lens wearers’ everyday lives.

Pay / Benefits

  • 25 days holiday
  • pension scheme
  • Wellness Platform for mental health and wellbeing
  • discounted contact lens scheme
  • LinkedIn Learning access
  • extensive training and career development

Responsibilities

  • Plan and prepare validation activities for projects
  • Assist in developing and executing installation, operational and performance qualifications
  • Lead risk management for local changes and support evaluation against FMEA documents
  • Support CAPA activities and drive timely corrective/preventive actions
  • Monitor process performance and trends; provide quality-based solutions
  • Involve in new product/process introductions and change management
  • Provide quality support for internal and external audits and participate in audit activities
  • Approve and maintain quality workflows in eQMS and train teams on CAPA and Validation

Key requirements

  • Minimum 3 years QA experience in a regulated industry
  • Knowledge of GMP / ISO 13485 / FDA QSR regulations
  • Experience with ISO 14971 risk management
  • Auditor training completed
  • Experience with validation protocols and reports
  • Degree level education or equivalent experience
  • Lean Manufacturing and/or Six Sigma knowledge
  • Full driving license
  • Excellent written and verbal communication
  • Excellent organizational skills
  • Ability to work independently and in a team
  • eQMS (quality workflows, CAPA and Validation)
  • CAPA management
  • Validation protocols and reports

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Posted: October 1st, 2026