Quality Engineer - Medical Devices | PFMEA & SPC

Joseph Michaels International; Sault Ste. Marie (MI); On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance (R

Job summary

Joseph Michaels International is seeking a Quality Engineer in Sault Ste Marie, Michigan, to join a growing medical device manufacturer. You will ensure product quality, process capability and regulatory compliance in a highly controlled manufacturing environment.

The role requires strong analytical abilities, attention to detail, and experience supporting quality systems in manufacturing. This position collaborates with manufacturing, engineering, suppliers, and customers to maintain high

Qualifications

• Bachelor’s degree in engineering required.
• 3+ years of quality engineering experience in manufacturing.
• Experience with measuring equipment and working with customers/suppliers.

Responsibilities

• Support quality activities across manufacturing operations.
• Develop and maintain inspection plans for new and existing products.
• Lead CAPA and MRB activities and participate in New Product Release Reviews.
• Develop and maintain PFMEA and Control Plans.
• Conduct process capability and statistical analysis.
• Develop and maintain SPC programs and perform Gage R&R.
• Conduct vendor audits and supplier quality activities.
• Train employees on quality procedures and inspection standards.

Skills

Analytical skills

Attention to detail

Regulatory compliance knowledge

Education

Bachelor’s Degree in Engineering

Tools

Measuring equipment

Job description

Joseph Michaels International is seeking a Quality Engineer in Sault Ste Marie, Michigan, to join a growing medical device manufacturer. You will ensure product quality, process capability and regulatory compliance in a highly controlled manufacturing environment.

The role requires strong analytical abilities, attention to detail, and experience supporting quality systems in manufacturing. This position collaborates with manufacturing, engineering, suppliers, and customers to maintain high