Quality Assurance Specialist

2 days ago


Oxford, Oxfordshire, United Kingdom Skills Alliance Full time

**About the Role:**

We are seeking a motivated Quality Assurance Specialist to join our team at Skills Alliance. This is an opportunity to work in a fast-paced global medical device organisation committed to improving patient outcomes.

The successful candidate will oversee quality engineering, process control and inspection efforts in support of our in-house manufacturing effort while reflecting our core values of innovation, evidence, integrity, teamwork, respect, and commitment to transplantation.

**Key Responsibilities:**

  • Provide quality engineering body of knowledge guidance and leadership to department and organization.
  • Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
  • Define and implement process control & monitoring system to ensure product quality and consistency.

Requirements:

  • Bachelor's degree within an engineering discipline or equivalent
  • Minimum 3 years' experience working within quality at a medical device manufacture
  • Experience with Class II or III devices
  • Expert knowledge cGMP, 21 CFR 820, ISO13485, 14971
  • Estimated Salary: £60,000 - £80,000 per annum


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