Supplier Quality Management Engineer
1 month ago
X4 Life Sciences is seeking a dedicated Supplier Quality Engineer to enhance our team focused on the Medical Device sector.
This position requires a presence in the office for three days a week, with a competitive salary range based on experience.
Key Responsibilities:
- Conduct audits of primary suppliers to ensure compliance with ISO 9001:2016 and cGMP, following the established audit schedule. This role may necessitate travel.
- Verify that all suppliers are approved and regularly assessed in line with ISO 13485:2016 and 21 CFR Part 820.
- Oversee the Supplier Corrective Action Reports (SCAR) process, ensuring timely initiation and investigation of all reports.
- Assist suppliers during the SCAR process, providing support for root cause analysis as needed.
- 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 concerning suppliers related to 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 modifications and improvements, along with relevant Standard Operating Procedures (SOPs), are communicated to suppliers as necessary.
- 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.
Required Skills and Experience:
- Experience in Quality Assurance within the Medical Device industry.
- 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 trips.
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.
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