Quality Engineering Professional

6 days ago


Oxford, Oxfordshire, United Kingdom Skills Alliance Full time
Design Assurance Role: A skilled Design Assurance Engineer is required to join our team in Oxford, UK. As part of our global expansion, this role will focus on supporting quality assurance by ensuring regulatory compliant design life cycle documentation is produced.

The ideal candidate will have excellent communication skills and the ability to work effectively in a team environment. You will be responsible for confirming adherence to procedures and global standards, participating in design verification testing, and collaborating with R&D, Post-Market Engineering, and Quality teams.

Key Responsibilities:
  • Ensure compliance with regulatory standards and procedures for class III medical devices.
  • Collaborate with cross-functional teams to develop and implement quality control processes.
  • Develop and maintain documentation, including design specifications, test plans, and verification reports.

Required Skills and Qualifications:
  • Bachelor's degree in Engineering or a related field.
  • Minimum 3 years' experience in quality assurance within the medical device industry.
  • Knowledge of cGMP, 21 CFR 820, ISO13485, 14971, and other relevant regulatory standards.
  • Strong analytical and problem-solving skills, with the ability to work independently and as part of a team.

Salary Range: £55,000 - £75,000 per annum, dependent on experience.

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