Associate Engineer, Quality Assurance

$72,800 - $91,520/Yr

The Judge Group - Mahwah, NJ

Full-time - Entry Level

Mahwah, NJ

Administrative and Support Services

About the position

The Associate Engineer, Quality Assurance is an individual contributor role focused on ensuring the quality of medical devices through various quality assurance processes. The position requires a strong understanding of quality assurance documentation and procedures, as well as the ability to communicate effectively with suppliers and investigate nonconformances. This role is expected to operate independently with minimal supervision, applying professional expertise in a specialized field.

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 assurance matters.
• 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 Systems), Oracle, and I Factory.
• Manage engineering changes including ECR (Engineering Change Request), ECN (Engineering Change Notice), and CT (Change Tracking).

Requirements

• Medical device experience is highly preferred.
• Professional mastery of a specialized field of expertise, typically requiring a college degree or equivalent.
• Good knowledge and comprehensive understanding of processes, procedures, and systems related to quality assurance tasks.
• Ability to make judgements based on practice and previous experience.