Quality Engineer

Actalent; Irvine (CA); On-site; USD 75,768 - 96,432; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave

Job summary

Actalent in Irvine, CA is seeking a Sr. Quality Engineer to support a high-volume complaints/ investigations environment in the medical device or pharmaceutical industry.

The role centers on PIRs, risk analysis and root cause analysis, requiring comfort with backlog and fast-paced onsite work. The position involves collaboration with cross-functional teams, audits, and ensuring compliance with quality standards.

Qualifications

• 8–10 years of experience in Quality within medical device or pharmaceutical industries
• Risk Analysis and FMEA experience (required)
• Experience with investigations and customer complaints
• Familiarity with FDA CFR requirements and regulatory guidance
• Ability to quickly learn complaint handling and investigation analysis
• Equivalent experience supporting high-volume complaint environments

Responsibilities

• Review PIR customer complaint investigations, including assisting when PIR support is set aside
• Catch up and manage a high volume of customer complaints and PIR reviews
• Review investigations and perform investigations when technical writing support is unavailable
• Evaluate defective samples and units to support investigations and root cause analysis
• Support and guide the PIR team by providing direction and hands-on assistance
• Perform risk assessments related to product defects, including products already in the field
• Assess defect severity and determine potential impact (e.g., recall or batch concern)
• Ensure compliance with FDA CFR requirements and guidance documents
• Manage a sustained workload of complaints, including an active backlog

Skills

Investigations

Customer complaints

Risk analysis

FMEA

Root cause analysis

FDA CFR

Job description

Quality Engineer

We are seeking a Sr. Quality Engineer to support a high-volume complaints and investigations environment within the medical device or pharmaceutical

industry. This role will focus heavily on customer complaint investigations (PIRs), risk analysis, and root cause analysis. The ideal candidate is

highly experienced, quick to learn, and comfortable working through a significant complaint backlog in a fast-paced, fully onsite setting.

Job Function

• Establishes quality standards for products and processes and suggests modifications meant to prevent defects in components or final products


• Works closely with cross functional teams, including product design, product management and production, to identify and mitigate quality risks.


• Audits production processes, raw materials or suppliers/vendors to ensure that established quality standards are met.


• Conducts root cause analysis for defects, non conformities or other quality failures.


• May be responsible for ensuring compliance with formal external quality standards, such as ISO 9001.


• Frequently working in an office and production/manufacturing environment and occasionally in a warehouse or lab environment.

Key Responsibilities

• Review and support PIR customer complaint investigations, including assisting when PIR support is set aside


• Catch up and manage a high volume of customer complaints and PIR reviews


• Review investigations and perform investigations when technical writing support is unavailable


• Evaluate defective samples and units to support investigations and root cause analysis


• Support and guide the PIR team by providing direction and hands‑on assistance


• Perform risk assessments related to product defects, including products already in the field


• Assess defect severity and determine potential impact (e.g., recall or batch concern)


• Ensure compliance with FDA CFR requirements and guidance documents


• Manage a sustained workload of complaints, including an active backlog

Required Qualifications

• 8–10 years of experience in Quality within medical device or pharmaceutical industries only


• Risk Analysis and FMEA experience (required)


• Strong experience with:


• Investigations


• Customer complaints


• Pharmaceutical or medical device quality systems


• Demonstrated ability to perform root cause analysis and defect assessment


• Familiarity with FDA CFR requirements and regulatory guidance


• Ability to quickly learn complaint handling and investigation request analysis


• Equivalent experience supporting high-volume complaint environments

Workload & Environment

• Average complaint volume: 86–100 per month


• Current backlog: ~230 complaints


• Expected burn‑down rate: ~120 complaints per month


• Role requires focus, urgency, and the ability to work through investigations continuously

Training & System Access

• One‑month required training period


• During training:


• Candidate will begin reviewing investigations prior to system access


• No independent work may be performed until system access is granted


• Separate investigation review activities will be assigned while awaiting SAP access


• onsite.

If you're passionate about quality excellence and have strong expertise in quality risk management, we'd love to hear from you!

Job Type & Location

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

Pay and Benefits

The pay range for this position is $55.00 - $70.00/hr.

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 Aug 1, 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.