Quality Engineer (NCR Investigations & CAPA)

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

Benefits offered by this job

Medical benefits

401(k)

Life Insurance

PTO

Job summary

Actalent is seeking a Quality Engineer in Irvine, CA to support a high-volume FDA-regulated manufacturing environment, blending Quality Engineering and Quality Assurance responsibilities.

You will lead investigations of nonconformances, perform root cause analysis, review quality documentation, and drive CAPAs and risk assessments across cross-functional teams while ensuring timely closure and compliance with quality systems.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
• 3+ years in Quality Engineering/Quality Assurance in a regulated industry.
• Hands-on investigations for nonconformances, deviations, and quality events.
• Experience leading nonconformance, deviation, CAPA, and root cause investigations.
• Experience reviewing and approving quality documentation, including protocols and reports.
• Strong analytical, writing, and data interpretation skills.

Responsibilities

• Lead investigations of nonconformances, deviations, and quality events within manufacturing operations.
• Conduct root cause analysis and identify CAPAs.
• Review and approve quality documentation to ensure compliance.
• Support trending and quality data analysis for improvements.
• Perform risk assessments and support change control activities.
• Collaborate with Manufacturing, Engineering, Quality, and Operations to resolve issues.
• Provide QA oversight during validation protocols (IQ/OQ/PQ).
• Coordinate with floor personnel to ensure adherence to quality requirements.
• Support audits and regulatory compliance with investigation records and CAPA documentation.

Skills

Investigations of NCs/DEVs/quality

Root cause analysis

Data analysis & trends

Cross-functional collaboration

Quality documentation review

CAPA management

Risk assessments

Validation (IQ/OQ/PQ)

Regulatory quality systems

Education

Bachelor's degree in Engineering/Quality/Life Sciences

Tools

TrackWise

SAP

BDoc

Job description

Job Title: Quality Engineer

Job Description

This Quality Engineer role supports a high-volume, FDA-regulated manufacturing environment and combines both Quality Engineering and Quality Assurance responsibilities. You investigate nonconformances, perform root cause analysis, review and approve quality documentation, and ensure compliance with quality system requirements. You work cross-functionally with production, engineering, and quality teams to lead investigations, manage deviations and CAPAs, and provide QA oversight in a fast-paced regulated setting while managing multiple priorities and driving investigations to timely closure.

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.

Essential Skills

• 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.

Additional Skills & Qualifications

• Medical device or pharmaceutical manufacturing experience in a high-volume environment.
• Experience using TrackWise for quality event, CAPA, and deviation management.
• Experience with SAP for manufacturing, quality, or materials management.
• Experience with electronic document management systems such as BDoc.
• Experience performing risk assessments and quality trending analysis to support continuous improvement.
• Experience supporting internal and external audits and broader regulatory compliance activities.
• Experience in change control, validation, and quality control within a regulated manufacturing environment.
• Familiarity with CAPA management, NCMR processes, and cross‑functional manufacturing support.
• Ability to work effectively on projects involving raw materials, finished products, and plastic components.
• Flexibility to support multiple business units, taking primary ownership of one unit while assisting others as needed.

Work Environment

This role is based on-site in a high-volume medical device and pharmaceutical manufacturing environment. You work closely with technicians, supervisors, and cross‑functional teams on the production floor, supporting activities that span raw materials, in‑process operations, and finished products, including plastic components. The environment is fast‑paced and highly regulated, with robust FDA‑compliant quality systems and electronic tools such as TrackWise, SAP, and document management platforms used to manage quality events, documentation, and materials. You can expect to support one primary business unit while providing backup support to others, collaborating with a sizeable team of quality and manufacturing professionals. Standard hours generally follow a traditional daytime schedule, but you must be flexible and willing to come in outside of typical 8–5 hours when manufacturing or quality support is needed. The organization is in a growth phase and is a recognized market leader in its product space, offering the potential for long‑term assignment duration and possible conversion to a permanent role for strong performers. The company develops, manufactures, and markets innovative medical products and services designed with inherent safety features to address critical healthcare challenges such as opioid misuse, hospital‑acquired malnutrition, and hazardous drug exposure, fostering a mission‑driven culture focused on patient safety and product quality.

Job Type & Location

This is a Contract position based out of Irvine, CA.

Pay and Benefits

The pay range for this position is $45.00 - $50.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job‑related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Irvine,CA.

Application Deadline

This position is anticipated to close on Sep 18, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.