Associate Supplier Quality Engineer (Medical Devices)

$69,326 - $90,126/Yr

Ledgent - Mahwah, NJ

Full-time - Entry Level

Mahwah, NJ

Administrative and Support Services

About the position

The Associate Supplier Quality Assurance Engineer will work independently to ensure the quality of medical devices by reviewing and approving various quality assurance documents and processes. This role requires a strong understanding of supply chain operations and the ability to communicate effectively with suppliers to address nonconformances and corrective actions.

Responsibilities

• Read, understand, document, and approve PPAP (Production Part Approval Process)
• Understand and approve FAI (First Article Inspection), DCP (Document Change Proposal), PFMEA (Process Failure Mode and Effects Analysis), IGS (Inspection Guidelines), and manufacturing procedures
• Articulate effectively with suppliers regarding quality issues
• Investigate nonconformances and CAPAs (Corrective and Preventive Actions) with suppliers
• Apply knowledge of supply chain, operations, and production processes
• Utilize knowledge of PLCM (Product Lifecycle Management) tools such as OnePLM, Windchill, and SAP
• Work with production software including MES (Manufacturing Execution Systems), EPS (Enterprise Production System), Oracle, and I Factory
• Manage engineering changes (ECR - Engineering Change Request, ECN - Engineering Change Notice, CT - Change Task)

Requirements

• Bachelor's degree or equivalent in a relevant field
• Professional mastery of specialized quality assurance processes
• Ability to work independently with minimal supervision
• Strong judgment and decision-making skills based on practice and previous experience
• Good knowledge of processes, procedures, and systems related to quality assurance

Nice-to-haves

• Experience with medical device manufacturing
• Familiarity with regulatory requirements in the medical device industry
• Knowledge of statistical process control

Benefits

• Competitive pay rate ranging from $33.33/hr to $43.33/hr