Quality Engineer, Medical Devices | CAPA, SPC & PFMEA

Top Echelon Software LLC; Sault Ste. Marie (MI); Sur place; USD 90 000 - 100 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental insurance

Vision insurance

401k match

PTO

Relocation lump sum

Résumé du poste

Top Echelon Software LLC in Sault Ste Marie, Michigan is seeking a Quality Engineer to support manufacturing operations in a highly regulated medical device environment, focusing on product quality, process capability, and regulatory compliance.

You will develop and maintain quality systems, lead CAPA and process improvements, and work with suppliers, customers, and internal teams to drive continuous improvement and reliable high-quality surgical products.

Qualifications

• Bachelors degree in engineering.
• 3+ years of quality engineering experience in manufacturing.
• Experience with internal and external customers.
• Experience using multiple types of precision measuring equipment.
• Strong analytical skills and attention to detail.

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.

Formation

Bachelors Degree in Engineering

Outils

Six Sigma

SPC

Lean Manufacturing

PFMEA

Control Plans

Description du poste

Top Echelon Software LLC in Sault Ste Marie, Michigan is seeking a Quality Engineer to support manufacturing operations in a highly regulated medical device environment, focusing on product quality, process capability, and regulatory compliance.

You will develop and maintain quality systems, lead CAPA and process improvements, and work with suppliers, customers, and internal teams to drive continuous improvement and reliable high-quality surgical products.