Principal Quality Engineer

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 Job Type & Location This is a Contract position based out of Irvine, CA. Pay and Benefits 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) Workplace Type This is a fully onsite position in Irvine,CA.

Application Deadline This position is anticipated to close on Mar 25, 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.