Quality Engineer: NCR, CAPA & Root Cause Analysis

ACTalent; Irvine (CA); Sur place; USD 55 000 - 76 000; Plein temps

Résumé du poste

Actalent is seeking a Quality Engineer to support on-site manufacturing quality activities in Irvine, CA. The role focuses on investigating nonconformances, root-cause analysis, and driving compliant resolutions within a regulated medical device/pharma environment.

You will document findings, support CAPA and change controls, and collaborate with Operations, Quality, and Engineering to improve product quality. This is a 12-month contract-to-hire opportunity on-site in Irvine.

Qualifications

• Bachelor's degree in engineering or related technical field.
• 12+ years of professional industry experience after graduation.
• 13 years of experience within medical device or pharmaceutical manufacturing or other regulated environment.
• Hands-on experience with nonconformance investigations (NCR/NCMR).
• Strong root cause analysis experience.
• Experience with CAPA, risk mitigation, and change control.

Responsabilités

• Own and perform nonconformance investigations across two production units.
• Conduct root cause analysis to identify sources of discrepancies.
• Write clear investigation reports detailing findings, root cause, impacts, and actions.
• Support ~4 nonconformance closures per week with varying complexity.
• Collaborate across Operations, Quality, Mfg Engineering and production teams.
• Maintain compliant documentation per GDP and quality systems.
• Participate in CAPA activities and change control processes.
• Review drawings and procedures to ensure quality requirements are met.

Connaissances

Nonconformance investigations

Root cause analysis

CAPA & risk mitigation

Regulated manufacturing environment

Technical writing

Cross-functional collaboration

Excel data analysis

Power BI

PI Vision

GDP compliance

Formation

Bachelor's degree in engineering

Outils

Excel

Power BI

PI Vision

Description du poste

Actalent is seeking a Quality Engineer to support on-site manufacturing quality activities in Irvine, CA. The role focuses on investigating nonconformances, root-cause analysis, and driving compliant resolutions within a regulated medical device/pharma environment.

You will document findings, support CAPA and change controls, and collaborate with Operations, Quality, and Engineering to improve product quality. This is a 12-month contract-to-hire opportunity on-site in Irvine.