Quality Engineer - Medical Devices, SPC & CAPA

Top Echelon Software, LLC; Sault Ste. Marie (MI); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance (P

401k Match

PTO

Relocation Lump Sum

Job summary

Top Echelon Software, LLC in Sault Ste. Marie, MI, is seeking a Quality Engineer to support manufacturing operations in a high-regulation environment.

You will develop and maintain quality systems, lead improvements, and ensure conformity with industry standards to deliver high-precision surgical products. The role requires a Bachelor’s in Engineering and 3+ years of quality engineering experience in manufacturing, with hands-on work in PFMEA, SPC, CAPA, and inspection planning.

Qualifications

• Bachelor's degree in engineering or equivalent required.
• 3+ years of quality engineering experience in manufacturing preferred.
• Experience supporting manufacturing quality systems and audits.

Responsibilities

• 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 CAPA initiatives.
• Support process and product validation activities.
• Develop PFMEA and Control Plans.
• Conduct process capability and SPC analyses.
• 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.

Skills

Quality engineering

Process improvement

Analytical skills

Customer interaction

Education

Bachelor's Degree in Engineering

Tools

Gage R&R

SPC

PFMEA

Control Plans

CAPA

Job description

Top Echelon Software, LLC in Sault Ste. Marie, MI, is seeking a Quality Engineer to support manufacturing operations in a high-regulation environment.

You will develop and maintain quality systems, lead improvements, and ensure conformity with industry standards to deliver high-precision surgical products. The role requires a Bachelor’s in Engineering and 3+ years of quality engineering experience in manufacturing, with hands-on work in PFMEA, SPC, CAPA, and inspection planning.