Design Quality Engineer III

Job Description

Job Description

Job Title: Quality Engineer – TMV (Medical Device)

Compensation: $60-$75/hr

Overview

We are seeking a Quality Engineer to support and lead Test Method Validation (TMV) and PFMEA remediation activities within a medical device environment. This role will focus on improving quality systems, ensuring regulatory compliance, and strengthening risk management in a post-acquisition setting.

About the Company

The organization is a global leader in medical technology, focused on developing innovative devices and solutions that improve patient care. They operate in a highly regulated industry and emphasize quality, compliance, and continuous improvement across all aspects of our business. Our teams work collaboratively to deliver products that make a meaningful impact on patients and healthcare providers worldwide.

Key Responsibilities

• Lead PFMEA remediation efforts and perform risk assessments
• Develop and execute Test Method Validations (TMV)
• Conduct Gage R&R (GR&R) and measurement system analysis
• Ensure compliance with FDA Quality System Regulations and ISO standards (ISO 13485, ISO 14971)
• Collaborate with Engineering, Quality, and Operations teams to resolve quality issues
• Support audits and quality management system (QMS) integration activities
• Identify and implement process improvements to enhance product quality

Qualifications

• Bachelor’s degree in Engineering or related field
• 5+ years of experience in medical device quality engineering
• Strong experience with PFMEA, TMV, and statistical analysis tools
• Experience in design quality preferred
• Knowledge of FDA regulations and ISO standards
• Strong problem-solving and communication skills

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

The pay range for this position is $55.00 - $65.00/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)

This is a fully onsite position in Irvine,CA.

This position is anticipated to close on Jul 3, 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 View email address on ziprecruiter.com 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.