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Quality Systems Engineer
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Actalent 1 day ago Be among the first 25 applicants Join to apply for the
Quality Systems Engineer
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Actalent Job Description
As a Quality Systems Engineer, you will own and lead the execution of quality plan actions and deliverables to establish and enforce compliance for an additional site quality management system. You will collaborate closely with business partners to provide leadership regarding Quality System certification changes, execute site audit readiness, and support quality system changes and continuous improvement activities associated with the Legal Manufacturer quality system to comply with ISO: 2016, FDA QSR/QMSR (effective Feb 2026), EU MDR, and additional regulations. Your role will involve developing strategies and implementing changes for Quality & Compliance functions within the Neurovascular business, ensuring a high state of compliance while meeting business needs. Job Title: Quality Systems Engineer
Job Description
As a Quality Systems Engineer, you will own and lead the execution of quality plan actions and deliverables to establish and enforce compliance for an additional site quality management system. You will collaborate closely with business partners to provide leadership regarding Quality System certification changes, execute site audit readiness, and support quality system changes and continuous improvement activities associated with the Legal Manufacturer quality system to comply with ISO: 2016, FDA QSR/QMSR (effective Feb 2026), EU MDR, and additional regulations. Your role will involve developing strategies and implementing changes for Quality & Compliance functions within the Neurovascular business, ensuring a high state of compliance while meeting business needs.
Responsibilities
Own and lead execution of quality plan actions and deliverables for additional site quality management system setup and enforcement of compliance. Collaborate with business partners to provide leadership regarding Quality System certification changes. Execute site audit readiness and support regulatory compliance audits through audit readiness and backroom support. Support quality system changes and continuous improvement activities for compliance with ISO: 2016, FDA QSR/QMSR, EU MDR, and other regulations. Develop and implement strategies for Quality & Compliance functions within the Neurovascular business. Work cross-functionally with departments such as R&D, Regulatory Affairs, Regulatory Compliance, Source Quality, Lifecycle Management, Marketing, and Supply Chain. Conduct Quality System and Quality Manual updates. Ensure compliance with all Federal, State, local, and Company regulations, policies, and procedures. Perform other duties as assigned.
Essential Skills
6+ years of experience as a Quality Engineer. Experience leading quality plans and QMS build-out. Proficiency in Windchill and ETQ systems. Strong knowledge in compliance, quality assurance, and regulatory affairs. Experience with FDA and ISO regulations.
Additional Skills & Qualifications
Knowledge of neurovascular and medical device quality engineering. Experience with system integration.
Work Environment
This role is on-site, with work scheduled from Monday to Wednesday and every other Friday. The position involves working within the Neurovascular division, which is undergoing a significant transformation with the setup of a new QMS in Irvine. The team is preparing for a site qualification audit by Q1 2026, making this a critical hire to ensure compliance and operational readiness.
Pay and Benefits
The pay range for this position is $60.00 - $75.00/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 hybrid position in Irvine,CA.
Application Deadline
This position is anticipated to close on Jul 28, 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 for other accommodation options. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Quality Assurance Industries Business Consulting and Services Referrals increase your chances of interviewing at Actalent by 2x Get notified about new Quality System Engineer jobs in
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Quality Systems Engineer
role at
Actalent 1 day ago Be among the first 25 applicants Join to apply for the
Quality Systems Engineer
role at
Actalent Job Description
As a Quality Systems Engineer, you will own and lead the execution of quality plan actions and deliverables to establish and enforce compliance for an additional site quality management system. You will collaborate closely with business partners to provide leadership regarding Quality System certification changes, execute site audit readiness, and support quality system changes and continuous improvement activities associated with the Legal Manufacturer quality system to comply with ISO: 2016, FDA QSR/QMSR (effective Feb 2026), EU MDR, and additional regulations. Your role will involve developing strategies and implementing changes for Quality & Compliance functions within the Neurovascular business, ensuring a high state of compliance while meeting business needs. Job Title: Quality Systems Engineer
Job Description
As a Quality Systems Engineer, you will own and lead the execution of quality plan actions and deliverables to establish and enforce compliance for an additional site quality management system. You will collaborate closely with business partners to provide leadership regarding Quality System certification changes, execute site audit readiness, and support quality system changes and continuous improvement activities associated with the Legal Manufacturer quality system to comply with ISO: 2016, FDA QSR/QMSR (effective Feb 2026), EU MDR, and additional regulations. Your role will involve developing strategies and implementing changes for Quality & Compliance functions within the Neurovascular business, ensuring a high state of compliance while meeting business needs.
Responsibilities
Own and lead execution of quality plan actions and deliverables for additional site quality management system setup and enforcement of compliance. Collaborate with business partners to provide leadership regarding Quality System certification changes. Execute site audit readiness and support regulatory compliance audits through audit readiness and backroom support. Support quality system changes and continuous improvement activities for compliance with ISO: 2016, FDA QSR/QMSR, EU MDR, and other regulations. Develop and implement strategies for Quality & Compliance functions within the Neurovascular business. Work cross-functionally with departments such as R&D, Regulatory Affairs, Regulatory Compliance, Source Quality, Lifecycle Management, Marketing, and Supply Chain. Conduct Quality System and Quality Manual updates. Ensure compliance with all Federal, State, local, and Company regulations, policies, and procedures. Perform other duties as assigned.
Essential Skills
6+ years of experience as a Quality Engineer. Experience leading quality plans and QMS build-out. Proficiency in Windchill and ETQ systems. Strong knowledge in compliance, quality assurance, and regulatory affairs. Experience with FDA and ISO regulations.
Additional Skills & Qualifications
Knowledge of neurovascular and medical device quality engineering. Experience with system integration.
Work Environment
This role is on-site, with work scheduled from Monday to Wednesday and every other Friday. The position involves working within the Neurovascular division, which is undergoing a significant transformation with the setup of a new QMS in Irvine. The team is preparing for a site qualification audit by Q1 2026, making this a critical hire to ensure compliance and operational readiness.
Pay and Benefits
The pay range for this position is $60.00 - $75.00/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 hybrid position in Irvine,CA.
Application Deadline
This position is anticipated to close on Jul 28, 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 for other accommodation options. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Quality Assurance Industries Business Consulting and Services Referrals increase your chances of interviewing at Actalent by 2x Get notified about new Quality System Engineer jobs in
Irvine, CA . Santa Ana, CA $87,510.00-$107,719.00 2 days ago Rancho Santa Margarita, CA $70,000.00-$80,000.00 2 weeks ago Rancho Santa Margarita, CA $70,000.00-$90,000.00 3 weeks ago Irvine, CA $80,000.00-$85,000.00 1 week ago Newport Beach, CA $70,000.00-$110,000.00 10 months ago Santa Fe Springs, CA $72,000.00-$117,000.00 2 weeks ago Irvine, CA $70,000.00-$80,000.00 2 weeks ago Lake Forest, CA $85,000.00-$100,000.00 2 days ago Pomona, CA $91,100.00-$136,700.00 1 week ago Irvine, CA $70,000.00-$90,000.00 2 weeks ago Aerospace Quality Engineer (ARP4754 / APQP / NPI) (H/F) - SAFRAN ELECTRONICS & DEFENSE AVIONICS USA, LLC
Tustin, CA $105,000.00-$125,000.00 2 weeks ago Irvine, CA $96,000.00-$186,000.00 6 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr