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Quality Engineer

2 months ago

Oxford, Oxfordshire, United Kingdom X4 Life Sciences Full time

X4 Life Sciences is seeking a talented Supplier Quality Engineer to enhance our team dedicated to the Medical Device sector.

This position requires a commitment of three days on-site, with a competitive salary range based on experience.

Key Responsibilities:

  • Conduct audits of critical suppliers in alignment with ISO 9001:2016 and cGMP, adhering to the established audit schedule, which may necessitate travel.
  • Ensure supplier compliance through approval and regular evaluations as per ISO 13485:2016 and 21 CFR Part 820 standards.
  • Oversee the Supplier Corrective Action Reports (SCAR) process, ensuring timely initiation and thorough investigation of all reports.
  • Assist suppliers during the SCAR process, facilitating root cause analysis as necessary.
  • Contribute to the development of Key Performance Indicators (KPIs) to effectively monitor and manage supplier quality.
  • Support the new supplier approval process, including evaluations and re-evaluations.
  • Investigate supplier-related feedback, Post-Market Surveillance, or customer complaints.
  • Facilitate the Return Merchandise Authorization (RMA) process by coordinating with suppliers and assisting with material transfers.
  • Ensure that all design changes and improvements, along with relevant Standard Operating Procedures (SOPs), are communicated to suppliers as needed.
  • Act as a subject matter expert in your field by maintaining up-to-date knowledge of relevant procedures and specifications, including participation in external audits such as BSI and FDA.

Required Skills and Experience:

  • Experience in Quality Assurance within the Medical Device industry.
  • Proven supplier audit experience, with qualifications as a Lead Auditor for ISO 13485 and 21 CFR Part 820.
  • Familiarity with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP).
  • Willingness to travel extensively, including international assignments.

We encourage interested candidates to submit their CV for consideration. Additionally, if you know someone who may be a suitable fit, please feel free to share this opportunity as we offer a referral bonus for successful placements.