Quality Engineer - Data-Driven QA & Process Improvement

CooperVision

Southampton

On-site

GBP 42,000 - 62,000

Full time

47 hours ago
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Benefits offered by this job

25 days holiday
Pension scheme
Healthcare cover
Life assurance
Wellness Platform
Discounted contact lenses
LinkedIn Learning access

Job summary

CooperVision is seeking a Quality Engineer to ensure new projects meet QMS requirements and drive continuous quality improvements. The role acts as the main QA contact for UKM units, maintaining QMS procedures and promoting best practices within the Quality team.

The successful candidate will analyze data, support risk management, CAPA and ECO processes, and ensure manufacturing quality adheres to FDA/MDR/GMP standards in a fast-paced environment at the Hamble site.

Qualifications

  • Strong communication and influencing skills to promote quality practices.
  • Self-motivated, proactive with drive to improve and complete projects.
  • Excellent planning, organisation, and time management for multiple priorities.
  • Knowledge and experience of Quality Management Systems (QMS) incl. FDA, MDR, GMP/QSR.
  • Applied knowledge of SPC and Acceptance Sampling as statistical tools.
  • Ability to interpret technical docs and analyse data for quality improvements.

Responsibilities

  • Ensure all new projects meet QMS requirements and improve quality via data analysis and CI.
  • Serve as main contact for quality and compliance activities across UKM units.
  • Maintain and enhance QMS procedures, promote best practices, drive CI projects.
  • Lead risk management, FMEA and ECO/change control activities.
  • Support CAPA/NCR investigations and verify preventive actions taken.
  • Collaborate with QA team to stay audit-ready under FDA/MDR/GMP.

Skills

Communication skills
Proactive
Planning
Time management
QMS knowledge
Statistical quality tools
Data analysis
MS Office
QA experience
Lean/Six Sigma
Regulatory knowledge
Degree/Credentials
Driver's license

Education

Degree in relevant field

Tools

MS Office Suite

Job description

CooperVision is seeking a Quality Engineer to ensure new projects meet QMS requirements and drive continuous quality improvements. The role acts as the main QA contact for UKM units, maintaining QMS procedures and promoting best practices within the Quality team.

The successful candidate will analyze data, support risk management, CAPA and ECO processes, and ensure manufacturing quality adheres to FDA/MDR/GMP standards in a fast-paced environment at the Hamble site.

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