Senior Quality Engineer - Medical Devices, Lean/DFSS

gpac; Waterbury (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

gpac is seeking a senior quality engineer to drive quality initiatives from concept through production, ensuring robust designs and efficient processes. You will analyze data, lead cross-functional teams, and act as the primary technical liaison for quality concerns.

The role emphasizes structured problem solving, DFSS, and Lean Six Sigma in a regulated manufacturing environment, with hands-on experience in measurement and fixtures.

Qualifications

• BSME or related technical degree with strong analytical & design fundamentals.
• 7–10 years of industry experience, with 3–5 years QE in root cause analysis in regulated manufacturing.
• Experience in medical device components or similar regulated environment is preferred.

Responsibilities

• Apply QE initiatives from concept to production to ensure robust design and processes.
• Drive cross-functional collaboration to maintain product quality and performance.
• Serve as technical liaison with customers to address quality concerns and manage complaint resolution.
• Lead continuous improvement using Lean, Six Sigma, DFSS, and Shainin methods to reduce variation.
• Develop knowledge of precision measurement equipment (e.g., CMMs, vision systems) and train QC staff.
• Design fixtures and inspection tooling to streamline inspection and data collection.

Skills

Root cause analysis

Structured problem solving

Lean Six Sigma

Data analysis

Quality control

Measurement

DFSS

Education

B.S. in Mechanical Engineering

B.S. in a related technical discipline

Tools

Minitab

SPC

SolidWorks

Excel

Job description

gpac is seeking a senior quality engineer to drive quality initiatives from concept through production, ensuring robust designs and efficient processes. You will analyze data, lead cross-functional teams, and act as the primary technical liaison for quality concerns.

The role emphasizes structured problem solving, DFSS, and Lean Six Sigma in a regulated manufacturing environment, with hands-on experience in measurement and fixtures.