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CAPA Quality Engineer

Englewood, CO, US • Posted 1 day ago • Updated 1 day ago

Contract W2

On-site

Depends on Experience

Fitment

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Job Details

Skills

ISO 14971
CQE
Medical Device industry experience.
CAPA
QMS platforms
FDA
FMEA

Summary

JOB DESCRIPTION:

Seeking a Quality Engineer with 3 5+ years of experience in Quality Systems and CAPA management within a regulated industry, preferably Medical Devices. The candidate will be responsible for reviewing, remediating, and migrating legacy CAPA records into EtQ, ensuring compliance with FDA and ISO quality standards. This role partners with Quality, Regulatory, Operations, and Engineering teams to drive CAPA investigations, root cause analysis, corrective actions, and quality system improvements.

Key Responsibilities

Review, remediate, and migrate CAPA records into EtQ.
Manage CAPAs from initiation through closure.
Conduct gap assessments and documentation remediation.
Support root cause investigations and corrective/preventive actions.
Verify effectiveness of implemented actions.
Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, and internal procedures.
Collaborate with cross-functional teams on quality initiatives.
Support CAPA training, documentation, and process improvements.
Maintain accurate quality records and documentation.

Required Qualifications

Bachelor's degree in Engineering or related technical field.
3 5+ years of Quality Engineering experience.
Hands-on experience with CAPA processes and Quality Management Systems.
Experience with EtQ or other electronic QMS platforms.
Knowledge of FDA 21 CFR Part 820, ISO 13485, and quality system regulations.
Experience with Root Cause Analysis, FMEA, Risk Management, and Quality Investigations.
Strong technical writing, documentation review, and analytical skills.
Proficiency with Microsoft Office applications.

Preferred Qualifications

Medical Device industry experience.
Orthopedic device manufacturing experience.
Knowledge of ISO 14971 Risk Management.
Certified Quality Engineer (CQE).
Experience with Design Controls, Statistical Analysis, Nonconformance Management, and Regulatory Audits.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 90944144
Position Id: 8989108
Posted 1 day ago

Contact the job poster

Sumanth Parikh

Recruiter @ Synkriom

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CAPA Quality Engineer

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Job Details

Skills

Summary

Key Responsibilities

Required Qualifications

Preferred Qualifications

Sumanth Parikh

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