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Capa Engineer Jobs in California (NOW HIRING)

Hologic

Quality Engineer 3 - Risk Management

San Diego, CA · On-site

$76K - $98K/yr

The Quality Engineer Level 3 - Risk Management is an experienced individual contributor within ... Complaint handling, CAPA, nonconformance, change control, validation, and post-market surveillance ...

SaniSure LLC

Quality Engineer - Complaints

Camarillo, CA · On-site

$95K - $105K/yr

The Quality Engineer is responsible for root cause analysis, CAPA implementation, and continuous improvement initiatives to ensure product quality, sterility assurance, and regulatory compliance.

MicroVention

Sr. Engineer, Quality Systems

Aliso Viejo, CA · On-site

$100K - $125K/yr

This is a hands-on position in which the Senior Quality Systems Engineer is an active contributor ... Maintains CAPA process. * Partners with the CAPA owners to investigate issues related to audit ...

Foxconn-PCE Technology

QP Engineer

Santa Clara, CA · On-site

$120K - $140K/yr

Coordinate customer complaints, 8D/CAPA responses, internal/customer/QMS audits, audit findings ... Bachelor's degree in Engineering, Quality, Business Administration, or a related field required.

Cryoport Systems, LLC

Sustaining Engineer

Irvine, CA · On-site

$98K - $120K/yr

Leading root cause investigations, participating in the Material Review Board (NCM, CAPA, etc ... Managing engineering changes through ECO and change control processes * Supporting design ...

Machina Labs

Quality Engineer

Chatsworth, CA

$120K - $160K/yr

Lead root cause investigations and implement effective corrective and preventive actions (CAPA). * Partner with Engineering and Manufacturing to improve product quality, manufacturability, and ...

Machina Labs

$120K - $160K/yr

Lead root cause investigations and implement effective corrective and preventive actions (CAPA). * Partner with Engineering and Manufacturing to improve product quality, manufacturability, and ...

Machina Labs

Quality Engineer

Chatsworth, CA · On-site

$120K - $160K/yr

Lead root cause investigations and implement effective corrective and preventive actions (CAPA). * Partner with Engineering and Manufacturing to improve product quality, manufacturability, and ...

Naval Air Systems Command

INDUSTRIAL ENGINEER

San Diego, CA · On-site +1

$46K - $132K/yr

... and preventive actions (CAPA) necessary to prevent recurrence FOR GS-07 : Your resume must ... Understanding engineering principles and practices, some knowledge of work processes and ability to ...

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Capa Engineer information

See California salary details

$38.5K

$100.4K

$135.7K

How much do capa engineer jobs pay per year?

As of Sep 11, 2026, the average yearly pay for capa engineer in California is $100,420.00, according to ZipRecruiter salary data. Most workers in this role earn between $82,900.00 and $115,000.00 per year, depending on experience, location, and employer.

What is a CAPA engineer?

A CAPA (Corrective and Preventive Action) Engineer is responsible for identifying, investigating, and resolving quality issues in manufacturing or engineering processes. They analyze root causes of defects, implement corrective measures, and develop preventive strategies to ensure compliance with industry regulations. CAPA Engineers work closely with cross-functional teams to improve product quality, streamline processes, and maintain regulatory compliance. They also document findings, track action plans, and support continuous improvement initiatives to reduce future risks.

What are the main daily responsibilities of a CAPA engineer?

A CAPA Engineer's daily responsibilities typically include investigating potential or actual nonconformities, conducting root cause analyses, and developing corrective and preventive action plans to resolve and prevent future issues. They also collaborate closely with cross-functional teams such as manufacturing, quality assurance, and regulatory affairs to ensure solutions are practical and compliant with industry standards. Additionally, CAPA Engineers monitor the progress and effectiveness of implemented actions, prepare documentation for audits, and participate in continuous process improvement initiatives. This role is crucial for maintaining the highest quality standards and ensuring compliance in regulated industries such as medical devices or pharmaceuticals.

What are the key skills and qualifications needed to thrive in the CAPA engineer position, and why are they important?

To thrive as a CAPA Engineer, you need a solid background in quality engineering, root cause analysis, and process improvement, typically supported by a degree in engineering or a related technical field. Familiarity with CAPA management systems, quality standards such as ISO 13485 or ISO 9001, and tools like Six Sigma or FMEA is highly valuable. Strong problem-solving abilities, attention to detail, and effective communication skills distinguish top performers in this role. These competencies ensure effective identification, documentation, and resolution of quality issues, helping organizations maintain regulatory compliance and deliver high-quality products.

What are the most commonly searched types of Capa Engineer jobs in California?

The most popular types of Capa Engineer jobs in California are:

What are popular job titles related to Capa Engineer jobs in California?

For Capa Engineer jobs in California, the most frequently searched job titles are:

What job categories do people searching Capa Engineer jobs in California look for?

The top searched job categories for Capa Engineer jobs in California are:

What cities in California are hiring for Capa Engineer jobs?

Cities in California with the most Capa Engineer job openings:

Capa Engineer jobs near you
Infographic showing various Capa Engineer job openings in California as of September 2026, with employment types broken down into 80% Full Time, and 20% Contract. Highlights an 95% In-person, and 5% Hybrid job distribution, with an average salary of $100,420 per year, or $48.3 per hour.

Quality Engineer 3 - Risk Management

San Diego, CA • On-site

Hologic
Health Care and Social Assistance • 5 - 10K employees
Learn more about Hologicexternal

$76K - $98K/yr

Full-time

This job post has expired 3 days ago. Applications are no longer accepted.

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

Job description


The Quality Engineer Level 3 - Risk Management is an experienced individual contributor within Regulatory and Quality for Diagnostics. This role is responsible for performing and maintaining product and process risk management activities for medical device and/or in-vitro diagnostic products across the full product lifecycle. The position supports new product development, sustaining activities, manufacturing, supplier quality, post-market surveillance, complaints, CAPA, nonconformances, and change management.
The role partners with cross-functional teams, including Quality, Regulatory Affairs, R&D, Manufacturing, Customer Service, Commercial/Sales, Supplier Quality, and Post-Market teams, to ensure risk management activities are completed in accordance with applicable quality system requirements, FDA regulations, ISO 13485, ISO 14971, and other relevant medical device and IVD regulatory expectations.
Knowledge
  • Product and process risk management principles for medical devices and IVD products.
  • FDA Quality System requirements and applicable regulatory expectations.
  • ISO 13485 and ISO 14971 requirements.
  • QSR, CDRH, IVDR, MDR, MDSAP, and IEC 62304 regulations and standards.
  • Design controls and their relationship to risk management.
  • Hazard analysis, use-related risk assessment, fault tree analysis, DFMEA, PFMEA, safety risk analysis, product risk assessments, and benefit-risk evaluations.
  • Complaint handling, CAPA, nonconformance, change control, validation, and post-market surveillance processes.
  • Root cause analysis and corrective action methods.
  • Technical documentation, including requirements, specifications, verification and validation reports, manufacturing procedures, quality records, and risk files.
  • Audit and inspection readiness expectations for internal audits, external audits, regulatory inspections, and supplier audits.

Skills
The successful candidate should demonstrate the ability to:
  • Independently perform assigned risk management activities across product development, manufacturing, sustaining, and post-market lifecycle phases.
  • Develop, review, maintain, and evaluate risk management documentation and deliverables.
  • Assess whether product, process, software, supplier, manufacturing, service, or labeling changes introduce new hazards or affect existing risk controls.
  • Identify, verify, and evaluate the effectiveness of risk controls.
  • Interpret technical documentation and identify quality, compliance, or risk implications.
  • Produce clear, objective, technically accurate, and inspection-ready documentation.
  • Apply analytical thinking, problem-solving, root cause analysis, and risk-based decision-making.
  • Support cross-functional teams, design reviews, change review boards, CAPA teams, complaint investigations, and material review activities.
  • Provide subject matter input during audits, inspections, and readiness activities.
  • Manage multiple priorities and meet project timelines in a dynamic regulated environment.
  • Communicate effectively through written, verbal, and interpersonal interactions.

Behavior
  • Works independently on defined assignments while recognizing when escalation is needed.
  • Demonstrates strong attention to detail and a commitment to high-quality standards.
  • Collaborates effectively with stakeholders across Quality, Regulatory, R&D, Manufacturing, Supplier Quality, Customer Service, Commercial/Sales, and Post-Market teams.
  • Maintains objectivity and technical accuracy in risk documentation and assessments.
  • Supports a culture of compliance, inspection readiness, and continuous improvement.
  • Escalates complex risk questions, safety concerns, or unresolved risk acceptability issues to management or senior technical leaders.
  • Contributes constructively to cross-functional decision-making and risk-based discussions.
  • Adapts to changing priorities while maintaining focus on quality, compliance, and product safety.

Experience
  • A minimum of a Bachelor's degree in engineering, life sciences, biomedical sciences, quality, or a related technical discipline.
  • 5+ years of related experience in a regulated medical device, IVD, quality engineering, or product development environment.
  • Experience supporting risk management files, hazard analyses, FMEAs, design control documentation, change control, complaints, CAPA, and/or nonconformance processes.
  • Experience working on cross-functional teams in regulated product development or sustaining engineering environments.
  • Experience evaluating post-market information such as complaints, deviations, nonconformances, service data, and other feedback for potential risk impact.
  • Experience supporting internal audits, external audits, regulatory inspections, supplier audits, and inspection readiness activities.
  • Practical experience reviewing and maintaining risk files throughout product development, manufacturing, and post-market surveillance phases.

Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $98,500 - $154,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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