1

Capa Engineer Jobs (NOW HIRING)

Lead and develop quality analysts, quality engineers, or CAPA coordinators as applicable; provide coaching on quality systems, investigations, regulatory expectations, and talent development.

Lead and develop quality analysts, quality engineers, or CAPA coordinators as applicable; provide coaching on quality systems, investigations, regulatory expectations, and talent development.

It takes the imagination and passion of all of us-from design and engineering to the manufacturing ... CAPA Management & Governance * Own and manage the site CAPA program lifecycle, including initiation ...

It takes the imagination and passion of all of us-from design and engineering to the manufacturing ... CAPA Management & Governance * Own and manage the site CAPA program lifecycle, including initiation ...

Bachelor's degree in Engineering, Life Sciences, or a related field. * Experience in the Medical Device industry is required. * Strong knowledge of CAPA, Non-Conformances, Complaints, Audits, and ...

Partner with Manufacturing, Technical Services, Quality functions, and Engineering to ensure alignment and timely resolution of CAPA actions. * Drive continuous improvement initiatives to strengthen ...

Staff CAPA Specialist

Arlington, TN · On-site

$83K - $138K/yr

Bachelor's degree in Engineering, Science, or a related technical discipline. * Minimum 4 years of experience in CAPA, Quality Systems, Engineering, or a related function within a regulated industry.

Partner with Manufacturing, Technical Services, Quality functions, and Engineering to ensure alignment and timely resolution of CAPA actions. * Drive continuous improvement initiatives to strengthen ...

Staff CAPA Specialist

Arlington, TN · On-site

$83K - $138K/yr

Bachelor's degree in Engineering, Science, or a related technical discipline. * Minimum 4 years of experience in CAPA, Quality Systems, Engineering, or a related function within a regulated industry.

Showing results 21-40

Capa Engineer information

See salary details

$39K

$101.8K

$137.5K

How much do capa engineer jobs pay per year?

As of Sep 11, 2026, the average yearly pay for capa engineer in the United States is $101,752.00, according to ZipRecruiter salary data. Most workers in this role earn between $84,000.00 and $116,500.00 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.

More about Capa Engineer jobs

What cities are hiring for Capa Engineer jobs?

Cities with the most Capa Engineer job openings:

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

The most popular types of Capa Engineer jobs are:

What states have the most Capa Engineer jobs?

States with the most job openings for Capa Engineer jobs include:

What are popular job titles related to Capa Engineer jobs?

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

Infographic showing various Capa Engineer job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 87% Full Time, 9% Part Time, and 3% Contract. Highlights an 86% Physical, 4% Hybrid, and 10% Remote job distribution, with an average salary of $101,752 per year, or $48.9 per hour.

CAPA Manager

Salt Lake City, UT • On-site

Edwards Lifesciences Corporation
Medical Equipment and Supplies Manufacturing • 10K+ employees

Full-time

Posted 23 days ago


Edwards Lifesciences rating

8.2

Company rating: 8.2 out of 10

Based on 31 frontline employees who took The Breakroom Quiz


Job description

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our CAPA Manager position is a unique career opportunity that could be your next step towards an exciting future.
The CAPA Manager will be responsible for leading and continuously improving the Corrective and Preventive Action (CAPA) program within a regulated medical device environment. This role owns the CAPA process governance framework, provides oversight of CAPA execution, drives timely resolution of quality issues, facilitates robust investigations and root cause analysis, and partners with cross-functional teams to prevent recurrence of nonconformances. The CAPA Manager ensures CAPAs are effectively managed from initiation through verification of effectiveness while fostering accountability, continuous improvement, and patient-focused quality.
How you will make an impact:
  • Own and maintain the CAPA process governance framework; establish governance, metrics, escalation pathways, performance standards, review boards, and prioritization based on risk, regulatory impact, patient safety, and business needs.
  • Oversee Quality Systems CAPAs end-to-end from initiation through investigation, risk assessment, action planning, implementation, verification of effectiveness, disciplined tracking, and closure.
  • Coach and lead teams in structured problem-solving and RCA tools; review investigations to ensure root causes are evidence-based, distinguished from symptoms, and addressed through systemic corrective actions.
  • Ensure compliance with applicable FDA QSR/QMSR (21 CFR 820) requirements, ISO 13485, EU MDR, MDSAP expectations, global regulatory requirements, and internal quality procedures related to CAPA.
  • Develop and maintain CAPA dashboards, analyze performance trends, communicate CAPA performance and escalation needs, and drive measurable improvements in timeliness, recurrence reduction, closure quality, and effectiveness verification.
  • Partner with cross-functional stakeholders to build accountability, gain buy-in for systemic corrective actions, facilitate alignment, and drive prevention-focused quality improvements.
  • Lead and develop quality analysts, quality engineers, or CAPA coordinators as applicable; provide coaching on quality systems, investigations, regulatory expectations, and talent development.
  • Serves as the site-wide or large-scope CAPA owner, collaborating cross-functionally to facilitate alignment and drive actions that impact multiple teams.
  • Other incidental duties assigned by Leadership

What you'll need (Required Qualifications):
  • Bachelor's degree with six (6) years of relevant experience; or equivalent work experience based on Edwards criteria
  • Proven experience leading, owning, and driving Corrective and Preventive Actions (CAPAs) within a regulated industry environment.
  • Experience working within highly regulated industries such as medical devices, pharmaceuticals, biotechnology, aerospace, automotive, semiconductor, or other regulated manufacturing environments.

What else we look for (Preferred Qualifications):
  • Engineering of Scientific degree
  • Medical Device industry experience
  • Demonstrated experience serving as a CAPA process owner, governance lead, or quality systems subject matter expert.
  • Experience developing and managing CAPA governance frameworks, including performance metrics, review boards, escalation processes, and effectiveness verification programs.
  • Experience driving enterprise-wide quality system improvements that resulted in measurable improvements in compliance, CAPA timeliness, recurrence reduction, or overall quality system effectiveness.
  • Strong knowledge of quality management systems, root cause analysis methodologies, and structured problem-solving techniques.
  • Experience conducting and reviewing investigations, identifying systemic root causes, and implementing sustainable corrective actions.
  • Experience utilizing quality metrics and data analysis to drive process improvements and operational effectiveness.
  • Experience developing quality dashboards, trend analyses, and executive-level performance reporting.
  • Knowledge of risk management methodologies and their application within CAPA investigations and corrective action planning.
  • Strong project management experience leading complex, cross-functional initiatives involving Quality, Manufacturing, Regulatory Affairs, Engineering, and Operations stakeholders.
  • Lean, Six Sigma, or other continuous improvement certification and demonstrated application of continuous improvement tools.
  • Demonstrated ability to lead teams, mentor stakeholders, and drive continuous improvement initiatives.
  • Experience leading, coaching, or developing Quality Engineers, Quality Analysts, CAPA Coordinators, or other quality professionals.
  • ASQ certification such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent.
  • Experience working within medical device quality systems governed by FDA Quality System Regulation (21 CFR Part 820/QMSR), ISO 13485, EU MDR, and/or MDSAP requirements.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

What Edwards Lifesciences employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom


Edwards Lifesciences logo

About Edwards Lifesciences

Sourced by ZipRecruiter

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Industry

Medical equipment and supplies manufacturing

Company size

10,000+ Employees

Headquarters location

Irvine, CA, US

Year founded

1958