Quality Engineer - Medical Devices, CAPA & SPC

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

Benefits offered by this job

Health, Dental and Vision Insurance

401k Match

PTO

Relocation Lump Sum

Job summary

Accounting Search seeks a Quality Engineer to join a growing medical device manufacturer in Sault Ste Marie, Michigan. The role focuses on ensuring product quality, process capability, and regulatory compliance in a highly controlled environment.

You will develop quality systems, lead improvements, and work with manufacturing, engineering, suppliers, and customers to uphold high standards and drive continuous improvement. Relocation support may be available.

Qualifications

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

PFMEA

Education

Bachelor’s Degree in Engineering

Tools

Measuring Equipment

Job description

Accounting Search seeks a Quality Engineer to join a growing medical device manufacturer in Sault Ste Marie, Michigan. The role focuses on ensuring product quality, process capability, and regulatory compliance in a highly controlled environment.

You will develop quality systems, lead improvements, and work with manufacturing, engineering, suppliers, and customers to uphold high standards and drive continuous improvement. Relocation support may be available.