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Quality Assurance Engineer for Suppliers
2 months ago
X4 Life Sciences is currently seeking a talented Supplier Quality Engineer to enhance our team.
This position involves a combination of on-site collaboration and travel, focusing on ensuring supplier compliance with industry standards.
Key Responsibilities:
- Conducting audits of primary suppliers in line with ISO 9001:2016 and cGMP, adhering to the established audit schedule.
- Ensuring all suppliers are properly approved and regularly assessed in compliance with ISO 13485:2016 and 21 CFR Part 820.
- Managing the Supplier Corrective Action Reports (SCAR) process, ensuring timely initiation and investigation of all reports.
- Providing support to suppliers during the SCAR process, including facilitating root cause analysis as necessary.
- Assisting in the development of Key Performance Indicators (KPIs) to effectively oversee and enhance supplier quality.
- Contributing to the new supplier approval process, including evaluations and re-evaluations.
- Supporting investigations related to supplier feedback, Post-Market Surveillance, or customer complaints.
- Assisting with the Return Merchandise Authorization (RMA) process by coordinating with suppliers and managing material transfers.
- Ensuring that all design changes and improvements, along with related Standard Operating Procedures (SOPs), are communicated to suppliers as needed.
- Acting as a subject matter expert by maintaining up-to-date knowledge of relevant procedures and specifications, and participating in external audits.
Required Skills and Experience:
- Experience in Quality Assurance within the Medical Device sector.
- 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 trips.
We invite interested candidates to submit their CVs for consideration. Additionally, if you know someone who may be a suitable fit, please share their information as we offer a referral bonus for successful placements.
