Quality Engineer - NPD & Production Readiness

MPE Inc.; Milwaukee (WI); On-site; USD 80,000 - 110,000; Full time

Job summary

MPE Inc. is seeking a development-oriented Quality Engineer to advance both new product development/design transfer and site quality/sustaining production. You will partner with Engineering, Operations, Supplier Quality, and Quality Systems to support compliant product launches and production readiness.

The role emphasizes applying ISO 13485 and FDA/QMS requirements, leading investigations, and using statistical tools to improve processes and product quality across the manufacturing lifecycle.

Qualifications

• 2-5 years experience in manufacturing engineering or quality assurance.
• Familiar with FDA regulations and ISO 13485.
• Preferred CQE/Lean Six Sigma or similar certification.

Responsibilities

• Ensure ISO 13485, FDA/QMS requirements, customer requirements and MPE procedures are followed.
• Review drawings, specs, BOMs, work instructions, test criteria, labeling, packaging and other quality records for manufacturability and control.
• Support transfer and production readiness activities including FMEA, CTQs, control plans, PPAP, qualification/validation planning and reviews.
• Apply statistical tools to sampling plans, measurement systems, process capability, test planning and data review.
• Develop and maintain acceptance criteria, inspection/test methods, and production release evidence requirements.
• Plan, execute and document IQ/OQ/PQ or other qualifications as assigned.
• Provide site quality support for production including containment, NCR/MRB disposition and line issue resolution.
• Lead or support investigations for nonconformances, deviations, audit findings and CAPAs.

Skills

Quality engineering methods

Risk management

Data analysis

Root cause analysis

Education

Bachelor's degree in engineering or related

Tools

GR&R

PPAP/FAI

ERP/MRP systems

FMEA

Job description

MPE Inc. is seeking a development-oriented Quality Engineer to advance both new product development/design transfer and site quality/sustaining production. You will partner with Engineering, Operations, Supplier Quality, and Quality Systems to support compliant product launches and production readiness.

The role emphasizes applying ISO 13485 and FDA/QMS requirements, leading investigations, and using statistical tools to improve processes and product quality across the manufacturing lifecycle.