Principal Quality Engineer

For immediate consideration, please apply directly to this job posting AND email me at biacosta @actalentservices.com with the following:

1) word copy of resume

2) 2-3 professional references

3) 4-5 brief bullet points highlighting technical qualifications

Description

• Establish a scalable, compliant risk management framework, including procedures, templates, and traceability structure.

• Build the foundational infrastructure needed for future ISO 14971 adoption

• Lead remediation of existing risk management files to align with FDA’s updated QMSR expectations.

• Conduct hazard identification, risk analysis, and risk control evaluation for Class III devices

• Ensure full traceability across hazards, mitigations, design outputs, verification activities, and residual-risk assessments.

• Review, assess, and remediate transferred legacy risk documents.

• Serve as the primary technical expert on risk management for Design, Quality, and Regulatory teams.

• Partner with R&D to translate legacy development work into compliant design inputs, outputs, and verification evidence.

• Identify design documentation gaps that affect risk management integration.

• Support DHF structure, change control, and documentation remediation to ensure consistency and compliance.

Skills

Medical device, Risk management, Root cause analysis, Quality management system, Quality engineering, Design control, npi, Audit, Capa, Validation

Top Skills Details

Medical device,Risk management,Root cause analysis,Quality management system,Quality engineering,Design control,npi

Additional Skills & Qualifications

• 7 years experience in Medical Device Quality or R&D with a specialization in risk management.

• Demonstrated ownership of ISO 14971 based risk management for complex (Class II or III) devices with software

• Hands on experience creating or remediating risk frameworks, procedures and technical files.

• Deep familiarity with FDA Design Controls, QSR/QMSR, and risk based decision processes.

Experience Level

Expert Level

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

The pay range for this position is $69.00 - $85.00/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 Mar 24, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $69 - $85