At a Glance
- Tasks: Lead quality assurance processes and drive continuous improvement in a regulated manufacturing environment.
- Company: Join a dynamic team at a leading manufacturing company focused on quality excellence.
- Benefits: Enjoy a competitive salary, career growth opportunities, and a supportive work culture.
- Other info: Collaborate with cross-functional teams and mentor a skilled quality assurance team.
- Why this job: Make a real impact by ensuring product quality and compliance in a fast-paced environment.
- Qualifications: 5+ years of QA experience and strong knowledge of ISO 13485 and FDA requirements.
The predicted salary is between 56000 - 56000 £ per year.
Hours: Monday to Friday (Full Time)
Salary: £56,000 per annum
Location: Gloucester
Lead Quality Excellence in a Regulated Manufacturing Environment
Hawk 3 Talent Solutions are recruiting an experienced Quality Assurance (QA) Manager to drive quality performance, compliance and continuous improvement within a highly regulated production environment. This is a key leadership role responsible for ensuring products meet the highest standards, maintaining certification, and strengthening quality culture across the business. You will oversee quality systems, complaint investigations, internal audits, CAPA, change management and continuous improvement while leading a skilled team and working closely with Manufacturing, Supply Chain, Continuous Improvement and wider operations.
Key Responsibilities
- Develop, implement and maintain robust quality assurance processes
- Lead complaint investigations, internal audits, CAPA and change management
- Ensure efficient, compliant and effective quality management system processes
- Maintain ISO 13485 certification and support FDA Quality System compliance
- Reduce cost of poor quality and drive customer satisfaction
- Manage and mentor the Quality Officer, Quality Specialist and Validation Engineer
- Coordinate training and collaborate with the training and development team
- Work cross-functionally with CI, Supply Chain and Manufacturing
- Make independent decisions using sound judgement and initiative
- Manage spend within the quality assurance budget
General Responsibilities
- Follow all health, safety, environmental and quality procedures
- Maintain a clean, organised working environment
- Care for tools, equipment and adhere to company rules
- Participate in improvement teams and support development of others
- Undertake additional duties as required by business needs
Role Context
This role requires a methodical, organised individual capable of scheduling resources, managing priorities and delivering results within agreed timescales.
Knowledge And Skills Required
- Bachelor's degree in natural science, engineering, medical technology or equivalent
- Minimum 5 years QA experience in a regulated manufacturing environment
- Strong knowledge of ISO 13485:2016 and FDA Quality System requirements
- Experience with quality tools: 8D, CAPA, 5 WHY, PDCA, 5S
- Proven complaint investigation and resolution experience
- Strong problem-solving and project delivery skills
- High attention to detail and passion for quality and continuous improvement
- Proactive, fast learner, capable of working independently
Who We're Looking For
- Leads by example
- Is proactive and solutions-focused
- Takes ownership and accountability
- Builds strong cross-functional relationships
- Champions continuous improvement
- Thrives in a regulated, fast-paced manufacturing environment
Closing date: 20.08.26
Quality Assurance Manager in Gloucester employer: TipTopJob
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