Quality Engineer

Quality Engineer

Job Type: Permanent

Location: Oxford, England. Onsite.

A world-leading medical technology company developing innovative solutions are seeking a motivated Supplier Quality Engineer to join the team as part of its global expansion. This is an opportunity to work in an innovative, fast-paced global medical device organisation committed to improving patient outcomes.

The Supplier Quality Engineer will assist oversight of suppliers globally, this role is critical in upholding the company’s values of innovation, evidence, integrity, teamwork, respect, and commitment to transplantation. The role plays a key part in developing and maintaining oversight practices for the Supplier Quality function.

Responsibilities:

• Auditing of key suppliers to ISO 9001:2016 & cGMP in accordance with the supplier audit schedule. This role will involve significant travel at times.
• Ensure all suppliers are approved and routinely evaluated in accordance with ISO 13485:2016 & 21CFR Part 820 (other territories may apply)
• Administer the Supplier Corrective Action Reports (SCAR) process, ensure all are raised and investigated within a timely manner.
• Support suppliers throughout the SCAR process, facilitating root cause analysis when required.
• Assist with the creation of KPIs to effectively manage and monitor supplier quality.
• Assist with new supplier approval process, including new supplier evaluation/re-evaluation.
• Assist with the creation and updating of SOPs and WIs related to supplier quality management.
• Support investigation of suppliers involved with any feedback, Post-Market Surveillance or customer complaints.
• Support the RMA process by liaising with suppliers and assisting with material transfer.
• Maintain good working relationships with suppliers to ensure resolution of any CA arising from supplier audits are closed in accordance with the CA plan.
• Ensure all Design changes and implemented improvements and related SOP and other related documents are communicated to the supplier when required.
• Act as Subject Matter Expert for area of expertise by maintaining knowledge of the relevant procedures and specifications related to current job specification. To include participating in and supporting external audits e.g BSI, FDA etc.
• Support and complete any other work-related tasks set by the QC/QA Manager.

Requirements:

• Bachelor’s Degree in Engineering or related field
• Experience of working in Quality within the Medical Device industry
• Supplier Audit Experience - ISO 13485
• Working knowledge of GDP/GMP requirements
• Excellent organisation skills and good attention to detail
• Ability to travel and be out of the country for considerable periods of time
• Knowledge of Master Control (Desirable)

Please reach out to Emily.James@skillsalliance.com or call 02033765104 for further details.