Quality Engineer

Job Title: Quality Engineer Job Description
This role supports a high-volume, FDA-regulated manufacturing environment by combining Quality Engineering and Quality Assurance responsibilities. You will lead investigations of nonconformances and deviations, perform root cause analysis, manage CAPAs, review and approve quality documentation, and ensure compliance with quality system requirements. You will work cross-functionally with manufacturing, engineering, and quality teams to resolve production issues, support process improvements, and maintain high standards of product quality and regulatory compliance in a fast-paced setting.
Responsibilities
- Lead investigations of nonconformances, deviations, and quality events within manufacturing operations, ensuring each investigation is thorough and well-documented.
- Conduct detailed root cause analysis using tools such as Fishbone diagrams and 5 Whys to identify true causes of nonconformances and deviations.
- Develop, implement, and manage corrective and preventive actions (CAPAs) to address identified issues and prevent recurrence.
- Review and approve quality system documentation, including nonconformance reports (NCR/NCMR), validation protocols, and other quality records, to ensure compliance with internal procedures and regulatory requirements.
- Support trending activities by analyzing quality data to identify recurring issues, patterns, and opportunities for continuous improvement.
- Perform risk assessments associated with manufacturing processes, quality events, and changes, and document risk mitigation strategies.
- Collaborate closely with Manufacturing, Engineering, Quality, Operations, and other cross-functional teams to resolve production-related quality issues in a timely manner.
- Participate in change control activities, including review of proposed changes, impact assessments, and verification of implementation and effectiveness.
- Support product quality reviews and product profile activities by providing quality data, investigation outcomes, and risk assessments.
- Provide Quality Assurance oversight and final quality review as required, including sign-off on protocols and key quality documents.
- Review drawings, procedures, and related technical documentation to ensure they meet quality and regulatory expectations.
- Support validation activities by reviewing and signing off on IQ, OQ, and PQ protocols and reports, and ensuring process validation complies with applicable standards.
- Assist with quality control and quality management activities, including process validation and failure analysis, to maintain robust manufacturing processes.
- Support audits and regulatory compliance activities by providing documentation, explaining quality processes, and addressing observations.
- Ensure investigations and associated documentation are completed accurately, in compliance with FDA-regulated quality system requirements, and within established timelines.
- Manage multiple investigations, tasks, and priorities simultaneously in a high-volume manufacturing environment while maintaining high quality and compliance standards.
- Provide cross-functional support across multiple business units, serving as the primary Quality Engineer for one business unit while assisting others as needed.
- Offer flexible support outside traditional business hours when necessary to address urgent production or quality issues on-site.
Essential Skills
- Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
- At least 3 years of experience in Quality Engineering, Quality Assurance, or Manufacturing Quality in a regulated industry.
- At least 2 years of experience conducting investigations for nonconformances (NCs), including nonconformance reports (NCR/NCMR).
- Demonstrated experience leading nonconformance, deviation, CAPA, and root cause investigations in a manufacturing environment.
- Experience supporting manufacturing operations within a high-volume production environment.
- Strong understanding of FDA-regulated quality systems, Good Manufacturing Practices (GMP), and compliance requirements.
- Experience reviewing and approving quality documentation, including validation protocols and quality records.
- Proficiency in performing root cause analysis using tools such as Fishbone diagrams and 5 Whys.
- Experience with CAPA management, including defining, implementing, and verifying effectiveness of corrective and preventive actions.
- Experience performing risk assessments related to manufacturing processes and quality events.
- Experience with process validation, including IQ, OQ, and PQ activities.
- Strong analytical and problem-solving skills applied to manufacturing quality and failure analysis.
- Strong technical writing skills for authoring and reviewing investigation reports, CAPAs, and quality documentation.
- Proven ability to manage multiple investigations and priorities simultaneously in a fast-paced environment.
- Experience providing cross-functional support to manufacturing, engineering, and quality teams.
Additional Skills & Qualifications
- Experience in Medical Device or Pharmaceutical manufacturing environments.
- Experience using TrackWise for quality event and CAPA management.
- Experience using SAP in a manufacturing or quality context.
- Experience with electronic document management systems such as BDoc.
- Experience performing quality trending analysis and using data to identify systemic issues and improvement opportunities.
- Experience supporting internal and external audits and broader regulatory compliance activities.
- Background in quality assurance, quality control, quality engineering, and quality management within FDA-regulated industries.
- Experience with validation protocols and process validation activities in regulated manufacturing.
- Familiarity with medical device and pharmaceutical quality requirements, including GMP and FDA expectations.
- Ability to work effectively on projects, review technical drawings and procedures, and contribute to continuous improvement initiatives.
- Flexibility to adjust work schedule and provide support outside traditional 85 hours when needed.
Work Environment
This position is based on-site in a high-volume medical device and pharmaceutical manufacturing environment. You will work closely with a large team that includes technicians, supervisors, and quality professionals responsible for raw materials, in-process activities, and finished products across multiple business units. Each Quality Engineer is primarily responsible for one business unit while supporting others as needed, contributing to a collaborative and fast-paced operation. The facility operates under FDA-regulated, GMP-compliant conditions with a strong focus on patient safety and product quality. Work may involve reviewing drawings, procedures, and validation documentation, as well as supporting production activities on the manufacturing floor. The organization is in a growth phase and is a recognized leader in its product space, offering the potential for assignments to extend beyond six months and the possibility of longer-term opportunities. The company develops, manufactures, and markets innovative medical products and services designed to address critical healthcare challenges such as opioid misuse, hospital-acquired malnutrition, and hazardous drug exposure. The role may occasionally require flexibility to work outside traditional business hours to support manufacturing and quality needs on-site.
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 Oct 20, 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 [email protected] 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.