Quality Engineer, Medical Devices | CAPA, SPC & PFMEA

United Future; 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

United Future is seeking a Quality Engineer in Sault Ste. Marie, Michigan. You will support manufacturing operations, develop inspection plans, and lead CAPA and process improvements to ensure high-quality surgical products in a regulated environment.

The role requires a Bachelor’s degree in engineering and 3+ years of quality engineering experience, with familiarity in PFMEA, SPC, Lean, and Six Sigma practices. This onsite position offers relocation support and comprehensive benefits.

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
• Participate in Material Review Board (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 Statistical Process Control (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

Analytical thinking

Attention to detail

Quality systems experience

Process improvement

Education

Bachelor’s Degree in Engineering

Job description

United Future is seeking a Quality Engineer in Sault Ste. Marie, Michigan. You will support manufacturing operations, develop inspection plans, and lead CAPA and process improvements to ensure high-quality surgical products in a regulated environment.

The role requires a Bachelor’s degree in engineering and 3+ years of quality engineering experience, with familiarity in PFMEA, SPC, Lean, and Six Sigma practices. This onsite position offers relocation support and comprehensive benefits.