Quality Control Manager

Hawk 3 Talent Solutions; Colethrop; On-site; GBP 46,000 - 55,000; Full time

Job summary

A specialized recruitment agency presents an exciting opportunity for a Quality Control (QC) Manager in a regulated manufacturing environment. The experienced candidate will oversee QC functions, ensure compliance with ISO 13485 and FDA standards, and lead a dedicated team. This role demands strong organizational skills and the ability to manage multiple priorities effectively within a fast-paced setting. Join as a key player ensuring quality and safety in medical device production.

Qualifications

• 7+ years experience in quality control within regulated manufacturing or medical devices.
• Experience leading a quality control team.
• Strong understanding of ISO 13485:2016 & FDA requirements.

Responsibilities

• Oversee all QC activities ensuring compliance with regulatory standards.
• Develop and implement QC procedures.
• Lead a team of Goods In Inspectors and Quality Control Inspectors.

Skills

Quality control procedures

Statistical sampling

Data analysis

Problem-solving

Regulatory standards knowledge

Education

Minimum 7 years experience in QC role

Job description

Quality Control (QC) Manager

Location: Gloucester

Salary: £55,000

Advertised by Hawk 3 Talent Solutions

Are you an experienced Quality Control Manager with a strong background in regulated manufacturing or medical devices? Hawk 3 Talent Solutions are excited to present a fantastic opportunity for a QC leader to take ownership of quality control functions within a highly regulated, fast‑paced environment.

This role is perfect for someone who thrives on structure, compliance, continuous improvement and building high‑performing quality teams.

The Role

As the Quality Control (QC) Manager, you will oversee all QC activities across the business‑ensuring full compliance with ISO 13485, FDA 21 CFR Part 820, and associated regulatory requirements. You'll be responsible for developing and implementing QC procedures, validating test methods, managing QC personnel, and ensuring products meet the highest quality and safety standards before release.

You will lead a team of Goods In Inspectors and Quality Control Inspectors, ensuring effective inspection, testing and release processes that maintain customer satisfaction and regulatory compliance.

Key Responsibilities

• Develop, implement and manage QC plans, sampling strategies and inspection protocols
• Oversee incoming, in‑process and final product inspections
• Validate QC test methods and maintain compliance with ISO 13485 requirements
• Lead non‑conformance investigations and support CAPA activities
• Produce, review and maintain accurate QC documentation with full traceability
• Manage supplier quality performance and controls
• Train, mentor and guide QC staff on processes, testing and regulatory compliance
• Support internal, external and regulatory audits
• Analyse QC data to identify trends, risks and opportunities for improvement
• Ensure equipment used for QC activities is maintained, calibrated and fit for purpose
• Approve QC records, test reports and Certificates of Analysis
• Manage sterilisation suppliers and oversee sterilisation requirements
• Coordinate cleanroom and environmental monitoring activities

People Leadership

• Line management of Goods In, Final Inspection and Final Release Inspectors
• Cross‑functional collaboration with Supply Chain, Manufacturing and Continuous Improvement teams
• Support training coordination with the Learning & Development team

Decision‑Making & Autonomy

• Works with minimal supervision, independently managing day‑to‑day QC operations
• Uses initiative and sound judgement to solve problems and ensure QC compliance
• Responsible for managing spend within the QC budget

General Responsibilities

• Adhere to company health, safety, environmental and quality procedures
• Maintain an organised, compliant and safe working environment
• Care for company tools and equipment
• Actively participate in improvement initiatives
• Support personal and team development through training
• Undertake additional duties aligned with business needs

Role Context

This is a structured role requiring strong organisational skills, the ability to plan activities effectively and the confidence to manage multiple priorities in a regulated environment.

Knowledge & Skills Required

• Minimum 7 years’ experience in a QC role within regulated manufacturing or medical devices
• Proven experience leading a QC team
• Strong knowledge of quality control procedures and regulatory standards
• Practical experience in product non‑conformity investigation and resolution
• Excellent understanding of statistical sampling, data analysis and quality metrics
• Strong analytical and problem‑solving skills
• Ability to work independently with a proactive, solutions‑driven approach
• In‑depth knowledge of ISO 13485:2016 & FDA Quality System requirements (essential)
• Experience implementing or automating inspection practices (advantageous)

Why Apply?

• Take a lead role bringing high‑quality medical devices to market
• Work within a highly regulated, professional environment
• Opportunity to develop and improve QC systems and processes
• Lead, develop and mentor a dedicated quality team
• Play a critical part in ensuring product safety, compliance and customer confidence

How to Apply

If you're an experienced QC professional looking to make a significant impact within a forward‑thinking medical device manufacturer, apply today through Hawk 3 Talent Solutions.

If you would like to apply for the role of Quality Control Manager, then please email your CV to (url removed) or call Donna on (phone number removed).

Closing date is #removed#. Please note this could change subject to suitable applications.

Hawk 3 Talent Solutions are acting as an employment agency on behalf of its client.

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Hawk 3 Talent Solutions are committed to the selection, recruitment and development of the best people, basing judgements solely on suitability for the job. Whilst we endeavour to respond to all applications individually, due to high volumes, this is not always possible. Thank you for your interest in this role and we look forward to working with you in the future.