Quality Engineer

Quality Engineer (Direct Hire)

Location: Fruitport, MI

Shift: M-F, business hours

Pay: $80,000-100,000 annually, based on experience

Responsibilities

Utilizing Statistical Process Control (SPC) for data analysis

Leading Corrective and Preventive Actions (CAPA) and performing failure analysis

Acting as a customer liaison, managing complaints and developing corrective solutions

Conducting Gage R&R, PFMEA, and preparing Control Plans and Process Flow Diagrams as part of component validation (IQ, OQ, PQ)

Tracking and analyzing quality performance metrics to drive improvement

Ensuring compliance with ISO 9001 and ISO 13485 standards

Qualifications

3–5 years of experience in a Quality Engineering role within a manufacturing or regulated industry

Strong background in root cause analysis, non-conformance investigations, CAPA management, and validation activities (IQ/OQ/PQ)

Hands-on experience with Statistical Process Control (SPC), Gage R&R, Geometric Dimensioning & Tolerancing (GD&T), and Minitab

Proven ability to communicate directly with customers—resolving complaints, conducting problem-solving discussions, and ensuring satisfaction