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Capa Engineer Jobs (NOW HIRING)

Simtra BioPharma Solutions

CAPA Manager

Bloomington, IN · On-site

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

Boston Scientific

Sr Quality Analysis - CAPA Mentor

Valencia, CA · On-site

$89.60K - $121.50K/yr

The CAPA Mentor partners with CAPA owners, project teams, and Quality leadership to ensure timely, compliant, and effective corrective and preventive actions, while driving continuous improvement and ...

GRAIL

Quality CAPA Program Manager #4693

Durham, NC · On-site +1

We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are ... Lead GRAIL's CAPA program within the Quality Management System (QMS), including planning and ...

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How much do capa engineer jobs pay per year?

As of May 30, 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 job?

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 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 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.
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Capa Engineer jobs near you
Infographic showing various Capa Engineer job openings in the United States as of May 2026, with employment types broken down into 96% Full Time, and 4% Part Time. Highlights an 85% Physical, 4% Hybrid, and 11% Remote job distribution, with an average salary of $101,752 per year, or $48.9 per hour.

Investigation/CAPA Specialist

Mirus Consulting Group

Humacao, PR • On-site

Full-time

Posted 17 days ago

Job description

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.
Position Overview
The Investigation / CAPA Specialists to support Quality Systems and Manufacturing Operations within a highly regulated medical device manufacturing environment. These resources will play a critical role supporting deviation investigations, nonconformance management, root cause analysis, CAPA development, and quality system compliance activities associated with manufacturing, engineering, and operational processes. The candidates will work cross-functionally with Manufacturing, Quality Assurance, Engineering, Supply Chain, and Operations teams to ensure timely closure of investigations and implementation of sustainable corrective and preventive actions aligned with FDA and ISO regulatory expectations.
Key Responsibilities
Investigations & Quality Events
  • Lead and support investigations related to:
    • Nonconformances (NCs)
    • Deviations
    • CAPAs
    • Customer complaints
    • Manufacturing events
    • Process excursions
    • Equipment and documentation discrepancies
    • Perform detailed root cause analysis using methodologies (such as...5 Whys, Fishbone / Ishikawa, Fault Tree Analysis, Risk Assessments, Trend Analysis ...)
  • Ensure investigations are properly documented, technically justified, and closed within established timelines.
CAPA Management
  • Develop, implement, and track Corrective and Preventive Actions (CAPAs).
  • Evaluate CAPA effectiveness and sustainability.
  • Collaborate with cross-functional teams to ensure corrective actions address systemic issues.
  • Monitor CAPA metrics and identify recurring trends impacting quality performance.
Documentation & Compliance
  • Author and review investigation reports, CAPA records, technical assessments, and quality documentation.
  • Support documentation activities within electronic quality management systems (eQMS).
  • Ensure compliance
  • Support audit readiness initiatives and participate in internal/external audits.
Cross-Functional Collaboration
  • Partner with Manufacturing, Engineering, Validation, and Operations teams to evaluate process impact and implement corrective strategies.
  • Participate in risk assessments and continuous improvement initiatives.
  • Support escalation meetings and quality review boards when required.
  • Provide technical support during regulatory inspections and quality audits.
Required Qualifications
  • Bachelor's Degree in: Engineering, Chemistry, Microbiology, Life Sciences, Industrial Sciences or Related Technical Discipline.
  • Minimum:
    • 3 - 5 years of experience
  • Experience in Medical Device, Pharmaceutical, Biotechnology and FDA-regulated manufacturing environments.
Preferred Qualifications
  • Strong experience managing: Investigations, Deviations, Nonconformances and CAPA systems.
  • Hands-on experience with root cause analysis methodologies.
  • Experience using quality systems such as: TrackWise, Infinity, SAP, MasterControl, ETQ or Similar eQMS platforms.
  • Knowledge of: FDA regulations, ISO 13485, GMP requirements and Data Integrity principles.
  • Strong technical writing and documentation skills.
  • Experience supporting audit readiness and inspection support activities.
Key Technical Skills
  • Root Cause Analysis
  • CAPA Management
  • Investigation Writing
  • Nonconformance Management
  • Quality Systems
  • GMP Compliance
  • Risk Assessments
  • Technical Documentation
  • Problem Solving
  • Cross-Functional Coordination
  • Data Trending & Analysis
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.

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