Quality Systems Administrator - Medical Devices QA

CooperVision Limited; Southampton; On-site; GBP 32,000 - 45,000; Full time

Benefits offered by this job

Holiday entitlement

Pension scheme

Healthcare cover

Life assurance

Wellness platform

Job summary

CooperVision Limited is seeking a Quality Systems Administrator to join the UK R&D QA team at The Vision Centre, Southampton. The role focuses on supporting the UK R&D QMS and global initiatives within R&D QA.

You will monitor and improve all areas of the Quality System, including document control, batch record reviews, CAPA/NCR investigations, and audits. On-site work required in Southampton with travel if needed.

Qualifications

• Experience with quality systems in medical device manufacturing.
• Experience in quality assurance teams.
• Auditing experience desirable.

Responsibilities

• Manage Document Change Control Process and Simple Approvals, review DCOs and APPs, create document numbers.
• Review and approve Batch Records to ensure GMP/GDP compliance.
• Support CAPA and NCR investigations and close actions with root cause reviews.
• Support CAPA investigations, implementing and reviewing effectiveness.
• Support projects in Concept Feasibility, Design Control and Risk Management activities.
• Assist audits (ISO 13485, FDA 21 CFR 820) and supplier audits; communicate findings and close out actions.

Skills

Quality systems

Quality Assurance

Documentation

Communication skills

Organisational skills

IT skills

Relational databases

Education

Bachelor's degree in a relevant field

Tools

Word

Excel

Outlook

Relational databases

Job description

CooperVision Limited is seeking a Quality Systems Administrator to join the UK R&D QA team at The Vision Centre, Southampton. The role focuses on supporting the UK R&D QMS and global initiatives within R&D QA.

You will monitor and improve all areas of the Quality System, including document control, batch record reviews, CAPA/NCR investigations, and audits. On-site work required in Southampton with travel if needed.