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Senior Quality Assurance Engineer
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Flexicare Limited is seeking a highly skilled Senior Engineer Advanced Quality to join our growing global Quality Team. As a key member of our team, you will provide leadership and direction in quality assurance, control, and preventative activities within operations and other business functions.
Key Responsibilities:- Collaborate with R&D, clinical, and operations teams to ensure quality performance of products and processes.
- Mentor and provide oversight for validation plans, protocols, reports, and requirements specifications.
- Develop and improve processes for existing and new products using a risk-based approach.
- Lead risk management investigations for HHE, PFAs, NCs, and CAPAs.
- Review and approve change management activities from a risk and validation perspective.
- Interpret complaints and NC trends from a risk perspective and drive continuous improvement.
- Provide technical direction in optimization of validation methods and sampling.
- Participate in and lead internal and external audits with regulatory representatives.
- Support manufacturing and design transfers, leading quality activities.
- Coach and mentor R&D and other business functions in quality topics and activities.
- Previous experience in a regulated environment.
- Proficient understanding of Medical Device manufacturing processes.
- Proficient in ISO 13485, GDP, GMP.
- Good understanding of engineering and quality practices and methods.
- Lean Six Sigma training (desirable but not essential).
- Excellent communication skills and attention to detail.
- Strong leadership and mentoring behaviors.
- Proficient in all Microsoft Office packages.
- Competitive salary in accordance with experience and capabilities.
- Pension.
- Company performance bonus (paid annually).
- 33 days holiday per year (incl. Bank Holidays) plus Holiday Trading Scheme.
- Benefits package: Life Assurance (x2), Income protection (50% of salary), Health Cashplan (Medicash), Benefit pot - for spending on additional benefits.