Regulatory Quality Engineer
Job in
Santa Clara, Santa Clara County, California, 95051, USA
Listed on 2026-06-27
Listing for:
Actalent
Full Time
position Listed on 2026-06-27
Job specializations:
-
Engineering
Quality Engineering, Regulatory Compliance Specialist -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Location:
Santa Clara, CA (Onsite)
Experience Level: 5-7 years
About the Role
We are seeking a Regulatory Quality Engineer to support the Regulatory Affairs (RA) organization by ensuring compliance with quality systems and regulatory requirements. This role focuses on audit readiness, quality system improvements, risk mitigation, and regulatory compliance activities within a highly regulated environment.
Key Responsibilities
* Develop and maintain KPI dashboards to monitor regulatory and quality performance metrics
* Lead and support audit readiness initiatives, including risk identification, mitigation planning, and preventative actions
* Investigate non-conformances and manage Corrective and Preventive Actions (CAPAs), including implementation and effectiveness monitoring
* Support and improve quality management system (QMS) processes and procedures
* Manage and track regulatory post-approval commitments
* Drive continuous process improvement initiatives within the quality system
* Collaborate with cross-functional teams and global partners to ensure compliance and timely resolution of issues
* Participate in internal and external audits (front room and back room support)
* Contribute to Regulatory Affairs projects and strategic initiatives
Core Responsibilities & Activities
* Develop and execute audit plans for critical RA processes (e.g., mock audits, technical documentation reviews, archival and impact assessments)
* Manage audit findings and CAPA processes
* Oversee metrics reporting and KPI tracking
* Support change management activities, including change orders and procedural updates
* Track and maintain post-approval regulatory commitments
* Provide RA support during QMS audits and integration efforts
Required Qualifications
* 5-7 years of experience in Quality, Regulatory Affairs, or Compliance within a regulated industry
* Strong knowledge of Medical Device regulations (U.S. and CE)
* Experience working with Quality Management Systems (QMS) and compliance frameworks
Key Skills & Competencies
* Self-motivated and able to work independently
* Strong critical thinking and problem-solving skills
* Proven ability to troubleshoot issues and drive resolution
* Effective communication and cross-functional collaboration skills
* Ability to manage multiple priorities and projects simultaneously
* Detail-oriented with a focus on process improvement and compliance
Work Environment
This is an onsite role in Santa Clara, CA, requiring close collaboration with cross-functional teams in a regulated, fast-paced environment.
Job Type & Location
This is a Contract position based out of Santa Clara, CA.
Pay and Benefits
The pay range for this position is $48.00 - $50.00/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 Santa Clara,CA.
Final date to receive applications
This position is anticipated to close on Jul 2, 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 Clearly Rated 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 actalentaccom 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…
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