Advanced Resource Managers
Quality Engineering Specialist
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Advanced Resource Managers
Advanced Resource Managers are currently supporting one of our long term clients, a leading global medical device manufacturer, that develops innovative healthcare products used by millions of people worldwide. Operating in over 100 countries and known for its strong quality culture, advanced manufacturing operations and commitment to continuous improvement, this organisation offers an excellent opportunity to join a highly regulated and technically advanced production environment on a full-time permanent basis, based onsite in Hamble.
The Opportunity
Reporting to the Quality Engineering Manager, you will play a key role in ensuring all new projects meet Quality Management System (QMS) requirements and for improving product quality through data analysis and continuous improvement initiatives.
This position offers a blend of quality engineering, validation, risk management, process improvement and regulatory compliance activities, working closely with manufacturing, engineering and project teams across the business.
Key Responsibilities
- Support new product and process introduction projects
- Ensure compliance with Quality Management System (QMS) requirements
- Lead and support process validation projects, partnering with engineering and manufacturing teams to develop validation plans, protocols, IQ/OQ/PQ activities and final reports
- Facilitate and contribute to Risk Management and FMEA activities
- Support the training of their Risk Management/FMEA process
- Act as a designated Change Assessor, supporting Engineering Change Orders (ECOs), Change Control activities and Change Management training across manufacturing operations
- Analyse manufacturing quality data and identify improvement opportunities
- Monitor process capability, quality trends and performance metrics
- Lead structured root cause investigations and support CAPA and NCR activities
- Drive continuous improvement initiatives across manufacturing operations
- Collaborate with Engineering and Production teams to resolve quality issues and improve process performance
- Support compliance with FDA, MDR and GMP requirements
- Help maintain an audit-ready quality environment
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Requirements
- Experience within Quality Engineering, Quality Assurance or Manufacturing Quality
- Knowledge of medical device, pharmaceutical or other highly regulated manufacturing environments
- Experience with process validation activities
- Understanding of CAPA, NCR and root cause investigation methodologies
- Experience applying Risk Management and FMEA tools
- Knowledge of QMS requirements, GMP/QSR and regulatory standards
- Familiarity with FDA and MDR requirements is highly desirable
- Experience using quality tools such as SPC and statistical analysis
- Degree qualified in Engineering, Quality or a related technical discipline, or equivalent experience
- Lean Manufacturing and/or Six Sigma experience would be advantageous
- Full Driving Licence is required
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Why Join?
- Join a recognised global healthcare manufacturer
- Work on highly regulated and technically complex products
- Excellent career development and training opportunities
- Strong investment in employee development
- Competitive salary and benefits package including 25 days holiday, pension scheme, healthcare cover, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more
- Opportunity to contribute directly to products that improve quality of life for millions of people worldwide
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