MedTech Supplier Quality Engineer: Process Validation & CAPA

Actalent; Englewood (CO); On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave (PTO, Vacation or Sick)

Job summary

Actalent in Englewood, CO is seeking a Supplier Quality Engineer to strengthen supplier performance and integrate QMS processes. You will review supplier processes, validate data, and perform Cp/Cpk studies to ensure regulatory compliance.

This contract role offers hands-on exposure to medtech quality systems in a cross-functional team. Ideal candidates have 2+ years in supplier quality or quality engineering, knowledge of ISO and FDA QSR/QMSR environments, and experience with CAPA and audits.

Qualifications

• Experience in supplier quality, process validation, and manufacturing environments.
• Ability to perform MSA and Cp/Cpk studies.
• Interpretation of engineering drawings and GD&T.
• Experience with CAPA, supplier remediation, and audits.

Responsibilities

• Review and analyze supplier process, manufacturing, and quality data to identify gaps.
• Perform process validation and capability studies (Cp/Cpk).
• Collaborate with internal teams and suppliers to drive corrective actions.
• Develop quality controls and ensure compliance with regulatory standards.

Skills

Experience in supplier quality

Process validation

Measurement system analysis

GD&T interpretation

Education

Bachelor's degree in Engineering

CQE or ASQ certification preferred

Job description

Actalent in Englewood, CO is seeking a Supplier Quality Engineer to strengthen supplier performance and integrate QMS processes. You will review supplier processes, validate data, and perform Cp/Cpk studies to ensure regulatory compliance.

This contract role offers hands-on exposure to medtech quality systems in a cross-functional team. Ideal candidates have 2+ years in supplier quality or quality engineering, knowledge of ISO and FDA QSR/QMSR environments, and experience with CAPA and audits.