Quality Engineer - Process & Data Excellence (Onsite)

CooperVision Limited; Southampton; On-site; GBP 45,000 - 60,000; Full time

Benefits offered by this job

25 days holiday

Pension scheme

Healthcare cover

Life assurance

Wellness platform

LinkedIn Learning access

Discounted contact lens scheme

Job summary

CooperVision is seeking a Quality Engineer to join the Quality team in Southampton. The role focuses on ensuring new projects meet QMS requirements and improving product quality through data analysis and continuous improvement initiatives.

You will work with UKM units, support CAPA/NCR investigations, manage risk assessments (FMEA), and assist with ECO/change management. A strong regulatory background and collaborative approach are essential.

Qualifications

• Strong knowledge of QMS, FDA, MDR and GMP/QSR requirements.
• Applied data analysis and statistical quality tools like SPC.
• Excellent planning, organization and time management to manage multiple projects.

Responsibilities

• Involve in new product/process introduction ensuring QMS requirements.
• Support process validation activities and prepare validation plans/protocols/reports.
• Lead data trending, monitor trends, and drive CAPA/NCR investigations.
• Support ECO/Change Management and training for risk management processes.
• Ensure audit readiness in line with regulatory requirements.

Skills

QMS knowledge

Data analysis

Problem solving

Communication skills

Regulatory knowledge

Education

Degree in engineering or science

Tools

MS Excel

QMS software

Job description

CooperVision is seeking a Quality Engineer to join the Quality team in Southampton. The role focuses on ensuring new projects meet QMS requirements and improving product quality through data analysis and continuous improvement initiatives.

You will work with UKM units, support CAPA/NCR investigations, manage risk assessments (FMEA), and assist with ECO/change management. A strong regulatory background and collaborative approach are essential.