Quality Engineer

Software Placement Group, SPG; Sault Ste. Marie (MI); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Health, vision, and dental insurance

401k match

PTO and holidays plan

Job summary

Software Placement Group (SPG) in Michigan seeks two Quality Engineers to strengthen quality and reliability of surgical instrument manufacturing. You will support manufacturing operations, develop inspection plans, lead CAPA, and drive process improvements to meet regulatory standards.

A Bachelor's Degree in Engineering is required, with experience in MRB, PFMEA, SPC, vendor quality, internal/external customers, and use of precision measuring equipment; collaboration with suppliers and

Qualifications

• Bachelor's Degree in Engineering required.
• Experience 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

CAPA

MRB

Process validation

Gage R&R

SPC analysis

Vendor audits

Document control

Inspection planning

Education

Bachelor's Degree in Engineering

Job description

Location: Sault Ste Marie, MI | Schedule: Full-time, on-site

Overview

A growing medical instrument manufacturer specializing in orthopedic surgical instruments is seeking two Quality Engineers for its local plant. In this role, you'll help ensure the quality and reliability of surgical instruments used by hospitals and medical professionals around the world, supporting manufacturing operations, driving process improvement, and maintaining compliance with regulatory standards.

What you'll do

• 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

Required qualifications

• Bachelor's Degree in Engineering required
• Experience working with internal and external customers
• Experience using multiple types of precision measuring equipment

Preferred qualifications

• 3+ years of experience in quality engineering within a manufacturing environment preferred
• Experience with Six Sigma methodologies
• Experience with Statistical Process Control (SPC)
• Experience with Lean Manufacturing
• Experience with PFMEA and Control Plans

Compensation and benefits

• Competitive compensation
• Health, vision, and dental insurance
• 401k match
• PTO and holidays plan

Why this role

This is an opportunity to join a growing company impacting thousands around the world by providing needed surgical instruments.