Quality Engineer - Medical Devices | CAPA, PFMEA & SPC

KingRecruitingServices; Michigan; On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

401k Match

PTO

Relocation Lump Sum

Job summary

KingRecruitingServices is seeking a Quality Engineer in Sault Sainte Marie, MI to strengthen quality systems in a medical manufacturing setting. The role focuses on product quality, process capability, and regulatory compliance in a highly controlled environment.

The ideal candidate will have a Bachelor’s degree in Engineering and 3+ years in quality engineering, with experience in CAPA, PFMEA/Control Plans, SPC, and Gage R&R. Competitive salary and relocation support offered.

Qualifications

• Bachelor’s Degree in Engineering required.
• 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.
• Participate in MRB and New Product Release Reviews.
• Lead corrective and preventive actions (CAPA).
• Support and facilitate process and product validation activities.
• Develop and maintain PFMEA and Control Plans.
• Conduct process capability and statistical analysis.
• Develop and maintain SPC programs.
• Perform Gage R&R and Measurement System Analysis.
• Evaluate and improve inspection methods and quality procedures.
• Program and support inspection equipment.
• Conduct vendor audits and supplier quality activities.
• Support internal and external customer audits.
• Develop and update work instructions and quality documentation.
• Train employees on quality procedures and inspection standards.
• Collaborate with suppliers and customers to standardize inspection processes.

Skills

Six Sigma

SPC

Lean

PFMEA & Control Plans

Education

Bachelor's Degree in Engineering

Tools

Gage R&R

Measurement System Analysis

Job description

KingRecruitingServices is seeking a Quality Engineer in Sault Sainte Marie, MI to strengthen quality systems in a medical manufacturing setting. The role focuses on product quality, process capability, and regulatory compliance in a highly controlled environment.

The ideal candidate will have a Bachelor’s degree in Engineering and 3+ years in quality engineering, with experience in CAPA, PFMEA/Control Plans, SPC, and Gage R&R. Competitive salary and relocation support offered.