Quality Engineer - Medical Devices | CAPA Leader

Kingfisher Recruiting; Sault Ste. Marie (MI); Vor Ort; USD 90.000 - 100.000; Vollzeit

Benefits dieser Stelle

Health insurance

401k Match

PTO

Relocation Lump Sum

Zusammenfassung

Kingfisher Recruiting is sourcing a Quality Engineer for a medical manufacturing site in Sault Ste. Marie, Michigan. The role focuses on ensuring product quality, process capability, and regulatory compliance within a highly controlled manufacturing environment.

The candidate will develop and maintain quality systems, lead improvement initiatives, and collaborate with manufacturing, engineering, suppliers, and customers to sustain high product quality and drive continuous improvement.

Qualifikationen

• 3+ years of quality engineering experience in manufacturing
• Experience with internal and external customers
• Experience using multiple types of precision measuring equipment

Aufgaben

• 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

Kenntnisse

Analytical ability

Attention to detail

Process improvement

Cross-functional collaboration

Ausbildung

Bachelor's degree in Engineering

Tools

Gage R&R

Precision measuring equipment

Statistical analysis software

Jobbeschreibung

Kingfisher Recruiting is sourcing a Quality Engineer for a medical manufacturing site in Sault Ste. Marie, Michigan. The role focuses on ensuring product quality, process capability, and regulatory compliance within a highly controlled manufacturing environment.

The candidate will develop and maintain quality systems, lead improvement initiatives, and collaborate with manufacturing, engineering, suppliers, and customers to sustain high product quality and drive continuous improvement.