Senior Supplier Quality Engineer (Medical Devices)

ACTalent; Englewood (CO); On-site; USD 69,000 - 83,000; Full time

Job summary

Actalent is seeking a Supplier Quality Engineer to lead capability studies and MSA improvements in a fully onsite Englewood, CO environment. You will partner with Quality, Manufacturing, and Development teams to drive supplier issues to closure and translate statistical results into actionable quality decisions.

The role requires 7+ years in quality disciplines, GD&T proficiency, and experience in regulated medical device manufacturing. A Six Sigma belt or CQE is preferred.

Qualifications

• Bachelor's degree in Engineering, Statistics, or a related technical discipline.
• 7+ years of Quality Engineering or Supplier Quality experience.
• Experience with GD&T, CTQs, process validation, and risk-based quality principles.
• Medical device or other regulated manufacturing experience preferred.
• CQE, Six Sigma Black Belt, or similar certification preferred.

Responsibilities

• Lead supplier process capability and MSA improvement activities.
• Perform Cp/Cpk and Pp/Ppk capability studies.
• Conduct Measurement System Analysis (MSA).
• Evaluate manufacturing and inspection data using SPC and statistical methods.
• Identify sources of variation and recommend corrective actions.
• Analyze normal and non-normal data and determine appropriate statistical methods.
• Review CTQs, GD&T, and process controls.
• Collaborate with Supplier Quality, Manufacturing, Development, and Quality teams to drive issue closure.
• Translate statistical findings into practical manufacturing, inspection, and supplier-quality decisions.

Skills

MSA analysis

Cp/Cpk analysis

SPC methods

Data interpretation

Supplier quality

Education

Bachelor's degree in Engineering/Statistics

Job description

Actalent is seeking a Supplier Quality Engineer to lead capability studies and MSA improvements in a fully onsite Englewood, CO environment. You will partner with Quality, Manufacturing, and Development teams to drive supplier issues to closure and translate statistical results into actionable quality decisions.

The role requires 7+ years in quality disciplines, GD&T proficiency, and experience in regulated medical device manufacturing. A Six Sigma belt or CQE is preferred.