Quality Engineer Nonconformance & CAPA

Job Title: Quality Engineer

Job Description

The Quality Engineer supports quality activities within an on-site manufacturing operation, with primary responsibility for investigating and documenting manufacturing nonconformances across two production business units. The role focuses on identifying root causes of manufacturing and product issues, assessing impacted products and lots, and driving timely, compliant resolutions in a regulated environment.

Responsibilities

• Own and perform nonconformance investigations related to manufacturing and product quality issues across two production business units.

• Conduct thorough root cause analysis to determine the source of manufacturing discrepancies and quality events.

• Write clear, technically sound investigation reports that document findings, root cause, impacted lots and products, and recommended actions.

• Support approximately four nonconformance closures per week, adapting to varying investigation complexity, timelines, and related change controls.

• Partner with upstream and downstream teams to investigate issues across the entire manufacturing process, from raw materials to finished products.

• Analyze manufacturing and quality data using tools such as Excel, Power BI, and PI Vision to identify trends, risks, and improvement opportunities.

• Work cross-functionally with Operations, Quality, Manufacturing Engineering, supervisors, technicians, and production personnel to resolve quality issues.

• Maintain complete, accurate, and compliant investigation documentation in accordance with applicable quality system requirements and good documentation practices (GDP).

• Support and participate in CAPA activities, including risk mitigation and implementation of corrective and preventive actions stemming from investigations.

• Contribute to and support change control processes associated with manufacturing and quality improvements.

• Review drawings, procedures, and related technical documentation to ensure quality requirements are clearly defined and met.

• Apply knowledge of regulatory expectations, including FDA and ISO-related requirements, within a medical device or pharmaceutical manufacturing context.

• Support audits and internal quality assurance activities as needed.

• Collaborate with cross-functional teams to continuously improve nonconformance investigation processes and overall product quality.

Essential Skills

• Bachelor's degree in an engineering discipline or a related technical field.

• Minimum 12+ years of professional industry experience after graduation.

• 13 years of experience within medical device or pharmaceutical manufacturing, or another regulated manufacturing environment.

• Hands-on experience conducting nonconformance, NCR, NCMR, or deviation investigations, including ownership of investigations rather than only participation.

• Demonstrated experience performing structured root cause analysis.

• Experience with CAPA, risk mitigation, and change control in a manufacturing or production environment.

• Proven ability to write high-quality technical investigation reports and other quality documentation.

• Strong technical writing skills with attention to clarity, accuracy, and compliance with GDP.

• Strong problem-solving skills with the ability to analyze complex manufacturing and quality issues.

• Effective cross-functional communication skills, including the ability to work closely with Operations, Quality, Manufacturing Engineering, and production teams.

• Experience supporting a manufacturing or production environment, including interaction with technicians, supervisors, and engineering staff.

• Proficiency with Excel for data analysis and reporting.

• Familiarity with FDA-regulated or ISO-based quality systems and quality engineering or quality assurance practices.

Additional Skills & Qualifications

• Experience within medical device or pharmaceutical manufacturing environments is strongly preferred.

• Exposure to or experience with Power BI and PI Vision for data visualization and analysis.

• Experience in quality engineering, quality assurance, or related engineering disciplines.

• Experience with audits in regulated manufacturing environments.

• Knowledge of ISO standards relevant to quality systems and medical products.

• Experience managing and documenting nonconformances, including NCMR and NCR processes.

• Experience supporting investigations that lead to CAPA and change control activities.

• Ability to interpret and review engineering drawings, procedures, and related technical documentation.

• Comfort working in a growth-oriented organization with evolving processes and continuous improvement initiatives.

• Interest in long-term assignment opportunities, with potential for a 12month contract and possible extension based on performance and business needs.

Work Environment

This position is based on-site in a manufacturing environment that develops, manufactures, and markets innovative medical products and services for the healthcare industry. The facility focuses on products with inherent safety features that help address critical healthcare challenges, including opioid abuse issues, hospital-acquired malnutrition, and hazardous drug exposure. You will work closely with a large, diverse operations and quality team that includes technicians, supervisors, and engineering staff who manage raw materials, in-process work, and finished products. The environment is highly regulated and quality-focused, with established quality systems, FDA and ISO expectations, and strong emphasis on data-driven decision-making using tools such as Excel, Power BI, and PI Vision. The role involves regular interaction on the production floor, review of drawings and procedures, and participation in cross-functional projects. This is a 12month contract assignment with the potential to extend, offering the opportunity to contribute to a market-leading organization in a growth phase while supporting meaningful healthcare-focused products

Job Type & Location

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

Pay and Benefits

The pay range for this position is $40.00 - $55.00/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)

Job Type & Location

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

Application Deadline

This position is anticipated to close on Nov 13, 2026.

Workplace Type

This is a fully onsite position in Irvine,CA.

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.