Quality Engineer
Pernini Legal
Quality Engineer
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.)
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 instruments
Vacancy posted 1 day ago
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