Quality Engineer - Medical Devices, SPC & CAPA

KLA Industries; Sault Ste. Marie (MI); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

Health, Dental & Vision Insurance (BCB

401k Match

PTO

Relocation Lump Sum

Job summary

KLA Industries in Sault Ste. Marie, MI is seeking a Quality Engineer to support manufacturing operations, develop and maintain quality systems, and drive continuous improvement in a highly regulated medical manufacturing environment.

The ideal candidate will have a bachelor’s degree in engineering, 3+ years of quality engineering experience, and hands-on experience with MRB, CAPA, PFMEA, Control Plans, SPC, and measurement equipment. Relocation assistance is available.

Qualifications

• Bachelor’s degree in Engineering required.
• 3+ years of quality engineering in manufacturing preferred.
• Experience working with internal and external customers.

Responsibilities

• Support quality activities across manufacturing operations.
• Develop and maintain inspection plans for new and existing products.
• Lead CAPA and participate in MRB and NPD reviews.
• Develop PFMEA and Control Plans and conduct process capability analyses.
• Implement and maintain SPC programs and Gage R&R studies.
• Train employees on quality procedures and inspection standards.
• Coordinate supplier and customer quality activities and audits.

Skills

Quality engineering

CAPA

Process capability

Statistical analysis

MRB involvement

Education

Bachelor’s Degree in Engineering

Tools

Gage R&R

SPC software

Job description

KLA Industries in Sault Ste. Marie, MI is seeking a Quality Engineer to support manufacturing operations, develop and maintain quality systems, and drive continuous improvement in a highly regulated medical manufacturing environment.

The ideal candidate will have a bachelor’s degree in engineering, 3+ years of quality engineering experience, and hands-on experience with MRB, CAPA, PFMEA, Control Plans, SPC, and measurement equipment. Relocation assistance is available.