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Senior Quality Assurance Engineer
2 months ago
Flexicare (Group) Limited is a leading designer and global provider of medical devices that enhance patient care. With over 35 years of experience, we support clinicians worldwide with class-leading devices and a global network of subsidiaries across over 100 countries.
Key Responsibilities- Provide leadership and direction in quality assurance, control, and preventative activities within operations and other business functions.
- Mentor and provide technical direction across multiple areas of expertise.
- Work closely with R&D, clinical, and operations teams to ensure quality performance of products and processes.
- Initiate and lead in the development and improvement of processes for existing and new products using a risk-based approach.
- Lead regular risk meetings and oversee 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 a continuous improvement process.
- Participate in and lead internal and external audits with regulatory representatives.
- Act as a subject matter expert in risk management practices and tools.
- Proficient understanding of Medical Device manufacturing processes.
- Good understanding of engineering and quality practices and methods.
- Lean Six Sigma training (desirable but not essential).
- 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 (including bank holidays) plus holiday trading scheme.
- Benefits package including life assurance, income protection, health cash plan, and benefit pot.