Quality Assurance Manager

Brightpath Associates LLC

West Chester, PA

Oversees quality control activities for precision-machined medical device components. Responsible for inspection planning, First Article and in-process inspections, nonconformance management, ERP tracking, ISO compliance, and leading quality efforts across machining cells and shifts.

1. Must-Have Requirements:

 5+ years of quality experience in a precision machining environment

 Strong knowledge of blueprint reading and GD&T

 Experience performing FAIs and in-process inspections

 Experience with nonconformance investigations, MRBs, and corrective actions

 Familiarity with ISO 9001 and ISO 13485 quality systems

 Ability to train and mentor inspectors and machinists

2. Preferred Qualifications:

 CNC machining or Swiss machining experience

 Experience supporting internal audits and calibration programs

 ERP system experience in a manufacturing environment

 Engineering degree or equivalent hands-on experience