Quality Engineer — CAPA & Investigations (FDA-Regulated)

Actalent; Irvine (CA); Presencial; USD 62.000 - 69.000; Jornada completa

Descripción de la vacante

Actalent is seeking a Quality Engineer for a high-volume, FDA-regulated manufacturing environment. You will lead investigations of nonconformances, perform root cause analysis, review and approve quality documentation, and ensure compliance with quality systems.

You will work cross-functionally with Manufacturing, Engineering, and Operations to manage deviations and CAPAs, provide QA oversight, and ensure timely closure of investigations, while supporting audits and change control.

Formación

• 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 the ability to interpret data and identify 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.

Responsabilidades

• 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.

Conocimientos

Root cause analysis

CAPA management

Quality documentation

FDA-regulated QA systems

Investigations

Cross-functional collaboration

Risk assessment

Data analysis

Technical writing

NCR/NCMR handling

Educación

Bachelor's degree in Engineering, Quality, Life Sciences

Herramientas

TrackWise

SAP

BDoc

Descripción del empleo

Actalent is seeking a Quality Engineer for a high-volume, FDA-regulated manufacturing environment. You will lead investigations of nonconformances, perform root cause analysis, review and approve quality documentation, and ensure compliance with quality systems.

You will work cross-functionally with Manufacturing, Engineering, and Operations to manage deviations and CAPAs, provide QA oversight, and ensure timely closure of investigations, while supporting audits and change control.