Quality Systems Engineer

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Job Title: Quality Systems EngineerJob Description
We are seeking a highly experienced Level III Quality Systems Engineer to join our Quality and Regulatory team. This role is critical in ensuring the integrity and compliance of marketing claims associated with our medical devices. The ideal candidate will have a strong background in quality systems within the medical device industry and a proven ability to trace marketing claims to supporting engineering analyses and documentation. This individual will also be responsible for developing and maintaining SOPs related to the establishment and validation of marketing claims, with a focus on different user populations. Additionally, the role involves collecting and reviewing existing documentation to identify and substantiate claims, and training key stakeholders on the newly developed claims process.
Responsibilities
Collect and review existing internal documentation to identify potential marketing claims.
Organize and document findings to support traceability and validation efforts with the internal project team.
Investigate and validate marketing claims by tracing them to engineering analyses, risk assessments, and supporting technical documentation.
Evaluate claims for accuracy, scientific validity, and compliance with regulatory standards.
Assess claims made for different user populations to ensure appropriate substantiation.
Utilize Pepper Flow software to manage and maintain traceability of claims to source documentation.
Ensure all documentation is audit-ready and compliant with internal and external quality standards.
Develop, implement, and maintain Standard Operating Procedures (SOPs) for the creation, review, and approval of marketing claims.
Collaborate with cross-functional teams to align SOPs with business and compliance needs.
Partner with Regulatory Affairs to ensure claims meet global regulatory requirements.
Work closely with Engineering and Clinical teams to gather and interpret data supporting claims.
Provide training and guidance to internal stakeholders on claim substantiation processes.
Design and deliver training sessions for key stakeholders on the new claims process.
Ensure consistent understanding and adoption of the process across relevant departments.
Essential Skills
Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).
8–10 years of experience in Quality Systems or Regulatory Affairs within the medical device industry.
Strong understanding of FDA regulations and other relevant standards.
Experience with Pepper Flow or similar document control/traceability systems.
Demonstrated ability to critically evaluate scientific and engineering data.
Excellent written and verbal communication skills.
Strong organizational and project management skills.
Additional Skills & Qualifications
Familiarity with global regulatory environments (e.g., EU MDR, Health Canada).
Prior experience developing SOPs and quality documentation.
Knowledge of human factors and usability engineering as it relates to different user populations.
Work Environment
This position is onsite in Irvine, CA. The work environment is collaborative, involving cross-functional teams including Marketing, R&D, Regulatory, and Clinical departments. Employees enjoy 2 weeks of PTO and 10 client-paid holidays.
Pay and Benefits
The pay range for this position is $60.00 - $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)
Workplace Type
This is a fully onsite position in Irvine,CA.
Application Deadline
This position is anticipated to close on Aug 15, 2025.
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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Apply
Location:
Irvine, CA, United States
Category:
Architecture And Engineering Occupations

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