Quality Engineer – Medical Devices | Process Improvement & Compliance

Tom Trese Networking LLC; Sault Ste. Marie (MI); Sur place; USD 90 000 - 100 000; Plein temps

Avantages offerts par ce poste

Health, Dental and Vision Insurance

401k Match

PTO

Relocation Lump Sum

Résumé du poste

Tom Trese Networking LLC in Sault Ste. Marie, Michigan seeks a Quality Engineer to support manufacturing operations, develop quality systems, and drive continuous improvement in a regulated medical device environment.

The role emphasizes process capability, regulatory compliance, and collaboration with suppliers and customers. The candidate will lead inspection planning, CAPA, PFMEA, and SPC programs while ensuring high product quality and robust quality documentation.

Qualifications

• Bachelor's degree in engineering is required.
• 3+ years of quality engineering experience in a manufacturing environment preferred.
• Experience working with internal and external customers; familiarity with precision measuring equipment.

Responsabilités

• 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

Connaissances

Analytical skills

Attention to detail

Formation

Bachelor’s Degree in Engineering

Outils

Six Sigma

SPC

Lean Manufacturing

PFMEA & Control Plans

Description du poste

Tom Trese Networking LLC in Sault Ste. Marie, Michigan seeks a Quality Engineer to support manufacturing operations, develop quality systems, and drive continuous improvement in a regulated medical device environment.

The role emphasizes process capability, regulatory compliance, and collaboration with suppliers and customers. The candidate will lead inspection planning, CAPA, PFMEA, and SPC programs while ensuring high product quality and robust quality documentation.