Senior Quality Assurance Engineer

2 days ago

Mountain Ash Rhondda Cynon Taf, United Kingdom Flexicare (Group) Limited Full time
Join Our Global Quality Team

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.
Requirements
  • 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.
What We Offer
  • 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 more.

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