Qualifications:

• 4-year degree in Quality Engineering or related field

Desired:

• ASQ Certified Supplier Quality Engineer/ Auditor
• 2+ years working within GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820 (210/211 and ICH Q7 as applicable)

Responsibilities:

• Maintains Approved Supplier List (ASL)
• Assesses potential new suppliers for technical, quality, and manufacturing capabilities
• Supports Engineering and Inspection groups in analysis of incoming material defects
• Participates in Material Review Board (MRB) activities to disposition nonconforming material per process
• Coordinates with suppliers and identifies areas for supplier quality improvements
• Supports ongoing business and new product development introductions through managing the quality supply chain
• Supports Purchasing and Engineering group in supplier selection, either by identifying existing approved suppliers or new suppliers
• Develops and maintains the annual supplier audit plan. Schedules, prepares and conducts supplier site audits to determine the state of a potential supplier’s quality system in relation to ISO 13485, ISO 9001, and 21CFR Part 820 (and 210/211 and ICH Q7 as applicable). Ensures supplier audit findings are tracked to timely and adequate closure.
• Supports all necessary site audits (internal and external) as related to Supplier Management
• Conducts material supplier assessments, notifies supplier of nonconformances, issues SCARs, and reviews corrective actions and follow up activities
• Responsible for escalation, leading risk assessments, risk mitigations and communicates supplier risks based on performance
• Works closely with the supplier to develop control plans and support change control activities
• Leads cost reduction projects related to quality improvements to supplied materials and products
• Reviews supplier performance data and participates in the Supplier Score Card process
• Tracks, analyzes, and reports on supplier performance to management and other team members as necessary.
• Manages all nonconformances related to Supplier Quality processes