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Senior Quality Assurance Engineer

2 months ago


Mountain Ash, United Kingdom Flexicare Limited Full time
Job Title: Senior Engineer Advanced Quality

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.
Requirements:
  • 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.
What We Offer:
  • 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.