Quality Engineer – Medical Devices, Relocation Support

RON SUNSHINE ASSOCIATES LLC; 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

RON SUNSHINE ASSOCIATES LLC in Sault Ste. Marie, Michigan, is seeking a Quality Engineer to support manufacturing operations and ensure regulatory compliance for high-precision medical devices.

The role focuses on developing quality systems, leading improvement initiatives, and driving CAPA, PFMEA, and SPC programs. The ideal candidate has a bachelor’s degree in engineering and 3+ years of manufacturing quality experience, with strong analytical skills and customer-facing collaboration

Qualifications

• Bachelor's degree in Engineering required.
• 3+ years of experience in quality engineering within a manufacturing environment.
• 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 Manufacturing

PFMEA

Control Plans

CAPA

Education

Bachelor’s Degree in Engineering

Tools

Measurement equipment

Gage R&R

Job description

RON SUNSHINE ASSOCIATES LLC in Sault Ste. Marie, Michigan, is seeking a Quality Engineer to support manufacturing operations and ensure regulatory compliance for high-precision medical devices.

The role focuses on developing quality systems, leading improvement initiatives, and driving CAPA, PFMEA, and SPC programs. The ideal candidate has a bachelor’s degree in engineering and 3+ years of manufacturing quality experience, with strong analytical skills and customer-facing collaboration