Senior CAPA & Quality Assurance Lead
Folkestone| Competitive Salary + Excellent Benefits
Quality Assurance | QA | CAPA | Root Cause Analysis | GMP | ISO 13485 | ISO 22716 | Medical Devices | Cosmetics | Lean Six Sigma | Investigations | Quality Systems
Are you an experienced Quality Assurance professional with a passion for solving complex quality issues and driving continuous improvement?
Our client, a highly respected manufacturer operating within the cosmetics and medical devices sectors, is seeking a Senior CAPA & Quality Assurance Lead to take ownership of complex investigations, corrective and preventative actions, and quality improvement initiatives across the business.
This is an excellent opportunity for an experienced QA professional to play a pivotal role in strengthening quality systems, reducing recurring issues and supporting regulatory compliance within a fast-paced manufacturing environment.
The Role
Reporting into the Quality leadership team, you will lead cross-functional investigations into quality events, identify root causes, coordinate robust CAPA activities and ensure effective implementation across the organisation.
Working closely with manufacturing, engineering, technical and global quality teams, you'll use data-driven analysis to improve processes, minimise risk and enhance compliance with GMP and ISO standards.
Key Responsibilities
Lead complex quality investigations, identifying root causes and implementing effective CAPA.
Support investigations into deviations, complaints, non-conformances and quality incidents.
Facilitate cross-functional problem-solving workshops using recognised root cause methodologies.
Coordinate CAPA activities, ensuring actions are completed on time and effectiveness is verified.
Conduct risk assessments and provide strategic recommendations to minimise future quality issues.
Review deviation reports, ensuring compliance with cGMP and internal quality procedures.
Analyse quality data, identify trends and produce KPI reports for senior management.
Drive continuous improvement initiatives across quality systems and manufacturing processes.
Support internal, customer and regulatory audits, acting as a Quality SME and backroom lead.
Review, develop and maintain Quality SOPs and documentation.
Collaborate with Global Quality teams on CAPA and continuous improvement programmes.About You
You'll be an experienced Quality Assurance professional who enjoys investigating complex problems and delivering practical, long-term solutions.
You will ideally have:
Extensive Quality Assurance experience within medical devices, cosmetics, pharmaceutical or other highly regulated manufacturing environments
Strong knowledge of GMP, ISO 13485 and ISO 22716
Proven experience leading CAPA investigations and root cause analysis
Experience managing quality deviations, complaints and non-conformances
Strong understanding of quality risk management
Experience analysing quality metrics and producing management reports
Excellent stakeholder management and communication skills
Ability to influence cross-functional teams and drive change
Lead Auditor qualification (desirable)
Lean Six Sigma Green Belt (minimum) or equivalentWhat's on Offer
Competitive salary
Comprehensive benefits package
Opportunity to influence business-wide quality improvements
Collaborative and supportive working environment
Career development within an international organisation
Exposure to global quality projects and continuous improvement initiativesIf you're an experienced Quality Assurance professional with strong CAPA and investigation expertise and are looking to make a real impact within a regulated manufacturing environment, we'd love to hear from you.
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