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Engineering
Validation Engineer
Sault Sainte Marie, MI
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A medical instrument manufacturing company in Sault Ste Marie, MI is looking to hire two Quality Engineers for their local plant. The company is growing and makes orthopedic surgical instruments for the medical industry. (Think surgical instruments that are hand or robot held and cut muscle, drill through bone, etc.) Position Overview The Quality Engineer will support manufacturing operations by developing and maintaining quality systems, leading process improvement initiatives, and ensuring compliance with regulatory standards. This individual will work closely with manufacturing, engineering, suppliers, and customers to maintain high product quality and drive continuous improvement. Key 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 Qualifications Education
Bachelor's Degree in Engineering required Experience
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 Technical Knowledge Preferred experience with:
Six Sigma methodologies
Statistical Process Control (SPC)
Lean Manufacturing
PFMEA and Control Plans Benefits Competitive Compensation Health, Vision and Dental Insurance 401k Match PTO and Holidays Plan Opportunity to join a growing company impacting thousands around the world by providing needed surgical instuments