Job Description

Role Purpose

The Quality Control Manager is responsible for overseeing all QC activities to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements. The QC Manager will be responsible for developing, implementing and maintaining quality control procedures, testing products, and overseeing the work of quality control inspectors. This role ensures that all medical devices meet established quality standards before release, manages QC personnel, and drives continuous improvement in testing processes and documentation. This position manages a team of Goods In and Quality Control Inspectors and is responsible for the inspection and release of products ensuring quality standards and customer requirements are met.

Key Objectives

Develop and implement QC plans, inspection protocols, and sampling strategies. Manage incoming, in-process, and final product inspections. Validate test methods related to QC activitieds and maintain compliance with ISO 13485 requirements. Manage nonconformance investigations and support CAPA process. Create and maintain accurate QC documentation and ensure traceability. Govern supplier quality management and controls. Manage, train and mentor QC staff on procedures and regulatory requirements. Support internal and external audits, including regulatory inspections. Analyze QC data to identify trends and drive continuous improvement. Ensure the correct equipment to carry out inspection activities correctly is available and calibrated and maintained. Review and approve QC records, test reports, and Certificates of Analysis. Manage sterilisation supplier and sterilisation requirements for the business. Coordinate and control support activities including cleanroom and environmental monitoring.

Knowledge and Skills

Management experience leading a team. Minimum 7 years' experience in quality control role in regulated production/manufacturing/medical device industry Experience of product non-conformity investigation and resolution In-depth knowledge of quality control procedures and legal standards Sound understanding of statistical sampling techniques and requirements Strong knowledge of mathematics, data analysis, and statistical methods Analytically minded Strong analytical, problem solving and project delivery skills with attention to detail Proactive, quick learner and capable of working independently Knowledge of ISO 13485:2016 (Quality System) and FDA Quality System requirements, requirements required Experience of automating inspection practices preferable
Job Type: Full-time

Pay: 50,000.00-60,000.00 per year

Benefits:

Company pension Flexitime Life insurance On-site parking Private dental insurance Private medical insurance
Application question(s):

Must be able to be primarily on site in the Gloucester Area for this role.
Experience:

Quality control: 5 years (required)
Work authorisation:

United Kingdom (required)
Work Location: In person