Quality Engineer - Medical Devices (CAPA/SPC)

Professional Recruiting Consultants, Inc.; Sault Ste. Marie (MI); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance (P

401k Match

PTO

Relocation Lump Sum

and much more

Job summary

Medical Manufacturing in Sault Ste Marie, MI, seeks a Quality Engineer to join a growing medical device manufacturer backed by a global industrial organization. You will support manufacturing operations by developing and maintaining quality systems, leading process improvements, and ensuring regulatory compliance in a highly controlled environment.

The role entails collaborating with suppliers and customers to standardize inspection processes, developing inspection plans, and driving CAPA, MRB,

Qualifications

• 3+ years of experience in quality engineering within a manufacturing environment preferred.
• Experience working with internal and external customers.
• Experience using multiple types of precision measuring equipment.

Responsibilities

• Support quality activities across manufacturing operations.
• Develop and maintain inspection plans for new and existing products.
• Lead CAPA and MRB processes.
• Develop and maintain PFMEA and Control Plans.
• Conduct process capability and SPC analyses.
• Perform Gage R&R and Measurement System Analysis.
• Support internal and external customer audits.
• Train employees on quality procedures and inspection standards.

Skills

Six Sigma

SPC

Lean Manufacturing

PFMEA & Control Plans

Education

Bachelor’s Degree in Engineering

Job description

Medical Manufacturing in Sault Ste Marie, MI, seeks a Quality Engineer to join a growing medical device manufacturer backed by a global industrial organization. You will support manufacturing operations by developing and maintaining quality systems, leading process improvements, and ensuring regulatory compliance in a highly controlled environment.

The role entails collaborating with suppliers and customers to standardize inspection processes, developing inspection plans, and driving CAPA, MRB,