Actalent
Principal Quality Engineer
Join to apply for the Principal Quality Engineer role at Actalent.
For immediate consideration, apply to this posting and email your resume to habels@actalentservices.com.
Job Description We’re seeking a Principal Quality Engineer to join our team and play a pivotal role in ensuring that our quality systems are impeccable. You will ensure that our products meet both regulatory and company standards, collaborating closely with various teams to ensure seamless and efficient operations.
Responsibilities
Guide and oversee product and process validations, including sterilization validation and revalidation.
Lead biocompatibility studies to ensure products meet necessary standards.
Create and update Risk Management documents according to ISO standards for new products or design changes.
Represent Quality Assurance on project teams for new or revised products.
Investigate product or production issues and develop corrective actions.
Oversee and assist in maintaining Calibration and Preventive Maintenance Systems.
Evaluate, develop, and monitor suppliers to ensure compliance with standards.
Support the maintenance of the quality system in compliance with Quality Policy and regulatory standards.
Provide support for regulatory submissions and audits.
Hold signature authority for changes to manufacturing/quality procedures, processes, and designs.
Provide training and direction for Quality Inspectors and Technicians.
Essential Skills
Bachelor’s degree required.
6+ years of experience as a Quality Engineer within Medical Device or Biotechnology industries.
Hands‑on approach in quality management.
Proficiency in design control, process validation, and biocompatibility.
Experience in regulatory compliance and sterile processing.
Skilled in root cause analysis, design validation, and CAPA.
Familiarity with cleanroom environments and cardiovascular devices.
Proficiency in Excel, particularly pivot tables.
Additional Skills & Qualifications
Experience in biocompatibility is a must for Principal level.
Experience with implantable medical devices is a plus.
Work Environment The position involves working in a medical device manufacturing setting, primarily focused on cardiovascular devices. You will spend approximately 90% of your time at the Lake Forest site and 10% at the San Clemente site.
Job Type & Location This is a Permanent position based out of San Clemente, CA.
Pay and Benefits The pay range for this position is $140,000.00 – $185,000.00 per year.
Internal employee benefits include but are not limited to: Medical, Dental, Vision, PTO, Holiday CA Sick Pay, and additional employee benefit options.
Workplace Type This is a fully onsite position in San Clemente, CA.
Application Deadline This position is anticipated to close on Dec 23, 2025.
About Actalent Actalent is a global leader in engineering and science 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 interview because of a disability, please email actalentaccommodation@actalentservices.com for additional accommodation options.
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For immediate consideration, apply to this posting and email your resume to habels@actalentservices.com.
Job Description We’re seeking a Principal Quality Engineer to join our team and play a pivotal role in ensuring that our quality systems are impeccable. You will ensure that our products meet both regulatory and company standards, collaborating closely with various teams to ensure seamless and efficient operations.
Responsibilities
Guide and oversee product and process validations, including sterilization validation and revalidation.
Lead biocompatibility studies to ensure products meet necessary standards.
Create and update Risk Management documents according to ISO standards for new products or design changes.
Represent Quality Assurance on project teams for new or revised products.
Investigate product or production issues and develop corrective actions.
Oversee and assist in maintaining Calibration and Preventive Maintenance Systems.
Evaluate, develop, and monitor suppliers to ensure compliance with standards.
Support the maintenance of the quality system in compliance with Quality Policy and regulatory standards.
Provide support for regulatory submissions and audits.
Hold signature authority for changes to manufacturing/quality procedures, processes, and designs.
Provide training and direction for Quality Inspectors and Technicians.
Essential Skills
Bachelor’s degree required.
6+ years of experience as a Quality Engineer within Medical Device or Biotechnology industries.
Hands‑on approach in quality management.
Proficiency in design control, process validation, and biocompatibility.
Experience in regulatory compliance and sterile processing.
Skilled in root cause analysis, design validation, and CAPA.
Familiarity with cleanroom environments and cardiovascular devices.
Proficiency in Excel, particularly pivot tables.
Additional Skills & Qualifications
Experience in biocompatibility is a must for Principal level.
Experience with implantable medical devices is a plus.
Work Environment The position involves working in a medical device manufacturing setting, primarily focused on cardiovascular devices. You will spend approximately 90% of your time at the Lake Forest site and 10% at the San Clemente site.
Job Type & Location This is a Permanent position based out of San Clemente, CA.
Pay and Benefits The pay range for this position is $140,000.00 – $185,000.00 per year.
Internal employee benefits include but are not limited to: Medical, Dental, Vision, PTO, Holiday CA Sick Pay, and additional employee benefit options.
Workplace Type This is a fully onsite position in San Clemente, CA.
Application Deadline This position is anticipated to close on Dec 23, 2025.
About Actalent Actalent is a global leader in engineering and science 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 interview because of a disability, please email actalentaccommodation@actalentservices.com for additional accommodation options.
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