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Remote Capa Engineer Jobs in Irvine, CA (NOW HIRING)

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Remote Capa Engineer information

See Irvine, CA salary details

$40.8K

$124.4K

$205.6K

How much do remote capa engineer jobs pay per year?

As of Aug 28, 2026, the average yearly pay for remote capa engineer in Irvine, CA is $124,368.00, according to ZipRecruiter salary data. Most workers in this role earn between $89,100.00 and $162,600.00 per year, depending on experience, location, and employer.

What is a remote CAPA engineer?

A Remote CAPA (Corrective and Preventive Action) Engineer is a professional responsible for identifying, investigating, and resolving quality issues within an organization, often working from a remote location. They analyze data, implement corrective and preventive measures, and ensure compliance with industry standards and regulations. Their work is crucial in maintaining product quality and safety, as well as continuous improvement in processes. Remote CAPA Engineers utilize digital tools and communication platforms to collaborate with cross-functional teams and document their findings.

How does a remote CAPA engineer typically collaborate with cross-functional teams to resolve quality issues?

As a Remote CAPA (Corrective and Preventive Action) Engineer, you’ll regularly work with quality assurance, manufacturing, R&D, and regulatory teams to identify, investigate, and resolve quality concerns. Collaboration often involves virtual meetings, sharing documentation, and following up on action items remotely. Effective communication skills and a proactive approach are crucial for driving investigations, ensuring timely implementation of corrective actions, and verifying their effectiveness. Building strong relationships across departments helps streamline issue resolution and fosters a culture of continuous improvement, even in a remote work setting.

What are the key skills and qualifications needed to thrive as a remote CAPA engineer, and why are they important?

To thrive as a Remote CAPA (Corrective and Preventive Action) Engineer, you need a solid background in quality engineering, root cause analysis, and regulatory compliance, often supported by a degree in engineering or a related field. Familiarity with quality management systems (such as ISO 13485 or FDA 21 CFR Part 820), CAPA software, and data analysis tools is typically required. Strong attention to detail, problem-solving skills, and effective virtual communication set standout professionals apart. These skills ensure accurate issue resolution, regulatory adherence, and seamless collaboration in distributed work environments.

What is the difference between Remote Capa Engineer vs Remote Quality Engineer?

AspectRemote Capa EngineerRemote Quality Engineer
CredentialsISO 13485, FDA regulations, Six SigmaISO 9001, Six Sigma, QA certifications
Work EnvironmentMedical device, pharmaceutical, biotech industriesManufacturing, software, product development
Industry UsagePrimarily healthcare and biotech sectorsBroad across manufacturing, tech, and software
Common Search IntentRegulatory compliance, CAPA processes, medical device qualityProduct quality, testing, process improvement

Remote Capa Engineers focus on managing corrective and preventive actions in regulated industries like healthcare, ensuring compliance with standards such as ISO 13485. Remote Quality Engineers work across various sectors to improve product quality through testing and process improvements. While both roles emphasize quality management, the industry focus and specific certifications differ.

What are the most commonly searched types of Capa Engineer jobs in Irvine, CA?

The most popular types of Capa Engineer jobs in Irvine, CA are:

What are popular job titles related to Remote Capa Engineer jobs in Irvine, CA?

For Remote Capa Engineer jobs in Irvine, CA, the most frequently searched job titles are:

What job categories do people searching Remote Capa Engineer jobs in Irvine, CA look for?

The top searched job categories for Remote Capa Engineer jobs in Irvine, CA are:

What cities near Irvine, CA are hiring for Remote Capa Engineer jobs?

Cities near Irvine, CA with the most Remote Capa Engineer job openings:

Remote Capa Engineer jobs near you
Infographic showing various Remote Capa Engineer job openings in Irvine, CA as of June 2026, with employment types broken down into 93% Full Time, 2% Part Time, and 5% Contract. Highlights an 38% Physical, 3% Hybrid, and 59% Remote job distribution, with an average salary of $124,368 per year, or $59.8 per hour.

Sr. Quality Assurance Engineer (ISO 13485)

Prismatik

Irvine, CA • On-site, Remote

$99K - $120K/yr

Full-time

Posted 10 days ago

Job description

We're looking for a Sr. QA Engineer to help build quality into every stage of our medical device development and manufacturing. You'll have broad ownership across quality engineering, risk management, CAPA, validation, and our Quality Management System. Working closely with cross-functional teams, you'll solve complex quality challenges, support new products and processes, and help ensure what we build meets the highest standards for safety, performance, and compliance.

Essential Functions:
  • Ensure compliance with applicable regulatory standards, including FDA 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR.
  • Lead and support CAPA investigations, non-conformance management, and root cause analysis using tools such as 8D, Fishbone, and 5 Whys.
  • Own and continuously improve elements of the Quality Management System (QMS), including document control, internal audits, supplier quality, and change control.
  • Collaborate cross-functionally with R&D, Manufacturing, and Regulatory Affairs to support design control, risk management (ISO 14971), and product development lifecycle activities.
  • Lead internal and supplier audits, and support external audits and inspections (e.g., FDA, Notified Bodies).
  • Participate in validation activities (IQ/OQ/PQ) for processes, equipment, and software used in manufacturing and quality operations.
  • Develop, monitor, and analyze quality metrics to identify trends, drive continuous improvement, and ensure effectiveness of corrective actions.
  • Provide quality engineering support to Quality Control, including guidance on inspection methods, metrology, and measurement system capability.
  • Conduct and document investigations of NCRs, complaints, and deviations, providing effective and sustainable corrective and preventive actions based on engineering analysis.
  • Lead and mentor junior engineers, fostering technical growth and reinforcing a culture of quality and compliance.
  • Integrate ISO 14971 risk management and IEC 62366 usability engineering activities within Glidewell/Prismatik processes.
  • Ensure organizational compliance with the QMS through ongoing training, education, and internal communication.
  • Collaborate with Manufacturing and Engineering to coordinate pilot production, process validations, and risk analyses for new products and processes.
  • Ensure calibration and preventive maintenance systems meet compliance and operational requirements.
  • Identify and implement process optimizations using Lean and Six Sigma methodologies to improve manufacturability, reduce risk, and enhance efficiency.
  • Identify opportunities for design or re-design of equipment, tools, and fixtures to improve manufacturing processes and product quality.
  • Perform other related duties and special projects as assigned by management.
Minimum Qualifications:
  • Bachelor's degree in Engineering, Science, or a related technical field.
  • Minimum of 5 years of experience in Quality Assurance or Quality Engineering within the medical device industry, or equivalent education and experience demonstrating comparable skills and knowledge.
  • Strong working knowledge of FDA regulations, ISO 13485, and other applicable international quality standards.
  • Hands-on experience with risk management (ISO 14971), design controls, and validation methodologies.
  • Proven analytical, problem-solving, and communication skills.
  • Proficiency in quality and statistical analysis tools such as Minitab or equivalent software.
  • Demonstrated project management experience.
  • Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma certification, preferred.
  • Experience with combination products or Class I/II medical devices, preferred.
  • Familiarity with EU MDR and UDI regulatory requirements, preferred.
Pay range: $99,000 - $120,000/yr.
Exact compensation may vary based on skills and experience.
This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.
Employment Type: full-time

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