Quality Engineer

2 weeks ago

Oxford, Oxfordshire, United Kingdom X4 Life Sciences Full time

X4 Life Sciences is currently seeking a talented Supplier Quality Engineer to enhance our team.

This position involves a hybrid work model, requiring on-site presence for a portion of the week.

Key Responsibilities:

  • Conduct audits of critical suppliers to ensure compliance with ISO 9001:2016 and cGMP standards, following the established audit schedule. This role may require occasional travel.
  • Verify that all suppliers are approved and regularly assessed in line with ISO 13485:2016 and 21 CFR Part 820, as applicable.
  • 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.
  • Help develop Key Performance Indicators (KPIs) to effectively monitor and manage supplier quality.
  • Support the new supplier approval process, including evaluations and re-evaluations.
  • Engage in investigations related to supplier feedback, Post-Market Surveillance, or customer complaints.
  • Assist with the Return Merchandise Authorization (RMA) process by coordinating with suppliers and managing material transfers.
  • Ensure that all design modifications and improvements, along with relevant Standard Operating Procedures (SOPs) and documents, are communicated to suppliers as needed.
  • Act as a subject matter expert in your field by staying informed about relevant procedures and specifications, including participation in external audits (e.g., BSI, FDA).

Required Skills and Experience:

  • Experience in Quality Assurance within the Medical Device sector.
  • Proven experience in Supplier Auditing, 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, we welcome referrals from your network, as we offer a referral bonus for successful placements.

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