Quality Engineer: CAPA & RCA Lead in FDA Ops

Actalent; Irvine (CA); On-site; USD 62,000 - 69,000; Full time

Benefits offered by this job

Medical, dental & vision

Critical Illness coverage

401(k) Retirement

Life Insurance

Disability Insurance

Health Spending Account

Transportation benefits

Paid Time Off

Job summary

Actalent in Irvine, CA seeks a Quality Engineer to join a fast-paced, FDA-regulated manufacturing environment. You will lead investigations of nonconformances, perform root cause analysis, and review quality documentation to ensure compliance with quality systems.

Responsibilities include managing CAPAs, supporting trend analysis, risk assessments, and cross-functional collaboration with production, engineering, and operations to drive quality improvements and timely closure.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
• 3+ years of Quality Engineering, Quality Assurance, or Manufacturing Quality experience in a regulated industry.
• At least 3 years of hands-on experience conducting investigations for nonconformances (NCs), deviations, and quality events.
• Demonstrated experience leading nonconformance, deviation, CAPA, and root cause investigations in a manufacturing setting.
• Experience supporting manufacturing operations within a high-volume production environment.
• Strong understanding of FDA-regulated quality systems, compliance requirements, and applicable standards.
• Proven ability to manage multiple investigations and priorities simultaneously in a fast-paced environment.
• Experience reviewing and approving quality documentation, including protocols, reports, and procedures.
• Strong analytical and problem-solving skills, including interpreting data and identifying trends.
• Solid technical writing skills for clear, concise, and compliant documentation of investigations, CAPAs, and risk assessments.
• Experience with nonconformance reports (NCR/NCMR) and quality control processes.
• Hands-on experience performing root cause analysis using structured tools and methodologies.
• Ability to collaborate effectively with cross-functional manufacturing teams and provide clear quality guidance.
• Experience with validation activities, including IQ, OQ, and PQ protocol review and approval.

Responsibilities

• Lead investigations of nonconformances, deviations, and quality events occurring within manufacturing operations.
• Conduct detailed root cause analysis and identify appropriate corrective and preventive actions (CAPAs).
• Review and approve quality system documentation to ensure compliance with internal procedures and regulatory requirements.
• Support trending activities and analyze quality data to identify recurring issues and opportunities for process and product improvement.
• Perform risk assessments associated with manufacturing processes and quality events.
• Collaborate closely with Manufacturing, Engineering, Quality, and Operations teams to resolve production-related quality issues.
• Participate in change control activities and contribute to process improvement initiatives across business units.
• Support product quality reviews and product profile activities to maintain high standards of product performance and safety.
• Ensure investigations are thorough, well-documented, compliant, and completed within established timelines.
• Provide QA oversight and final quality review of documentation, protocols, and reports as required.
• Sign off on validation protocols and reports for installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Review drawings, procedures, and related technical documentation for accuracy and compliance.
• Support audits and regulatory compliance activities by providing investigation records, CAPA documentation, and risk assessments.
• Offer cross-functional support across multiple business units, with primary responsibility for one unit and backup support for others as needed.
• Assist with quality control activities, including nonconformance reporting (NCR/NCMR) and change control processes.
• Use tools and methodologies to determine causes of deviations or nonconformances and recommend effective corrective actions.
• Engage in validation and verification activities related to manufacturing processes and equipment.
• Coordinate with technicians, supervisors, and other floor personnel to ensure quality requirements are understood and followed.

Skills

Quality engineering

Root cause analysis

CAPA management

FDA compliance

Investigation leadership

Documentation review

Education

Bachelor's degree in Engineering/Quality/Life Sciences

Tools

TrackWise

SAP

BDoc

Job description

Actalent in Irvine, CA seeks a Quality Engineer to join a fast-paced, FDA-regulated manufacturing environment. You will lead investigations of nonconformances, perform root cause analysis, and review quality documentation to ensure compliance with quality systems.

Responsibilities include managing CAPAs, supporting trend analysis, risk assessments, and cross-functional collaboration with production, engineering, and operations to drive quality improvements and timely closure.