What are the responsibilities and job description for the Supplier Quality Leader position at EPM Scientific?
A leading medical device company is seeking a Supplier Quality Leader to oversee supplier quality operations and ensure compliance across a global supply base. This role will play a key part in supporting product development, manufacturing, and regulatory readiness.
Key Responsibilities:
- Lead supplier quality activities across multiple product lines and manufacturing sites.
- Manage supplier audits, assessments, and performance monitoring.
- Collaborate cross-functionally to support new product introductions and process validations.
- Drive resolution of supplier-related nonconformances, CAPAs, and quality issues.
- Support validation efforts including IQ/OQ/PQ, Gage R&R, and other qualification protocols.
- Ensure compliance with applicable standards (e.g., ISO 13485, FDA QSR).
- Develop and maintain quality documentation and metrics related to supplier performance.
Qualifications:
- Minimum of 10 years of experience in quality assurance or supplier quality within a regulated industry, preferably medical devices.
- Strong background in supplier management, validations, and quality systems.
- Familiarity with CAPA, NCRs, FMEAs, and root cause analysis.
- Excellent communication and leadership skills.
Salary : $160,000 - $190,000
