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# SW QMS Specialist

- **Company:** Katalyst Talent Agency
- **Location:** South Plainfield, NJ, United States
- **Experience:** Expert
- **Salary:** $40,000.0 - $55,000.0
- **Contract:** Permanent contract
- **Skills:** Document Management Systems, Software Systems
- **Published:** September 18, 2026
- **Apply:** https://www.careerjet.com/job/us217d8065ea4825a76281e5e307283a24/eaa

## About the Role

* Bachelor's degree in Quality Management, Regulatory Affairs, Life Sciences, or a related field.
 * Minimum of 5 years of experience in QMS, quality assurance, regulatory compliance, or related roles.
 * Software/AI experience.
 * Strong knowledge of FDA and EU regulatory requirements, specifically with QMS.
 * Experience with CAPA processes, document management, and regulatory submissions.
 * Familiarity with cybersecurity audit procedures and standards.
 * Excellent communication skills, with a keen attention to detail and ability to manage multiple priorities.

Preferred Qualifications:

 * Certification in Quality Management or Regulatory Affairs (e.g., ASQ, RAPS).
 * Hands-on experience with QMS software systems.
 * Experience in the medical device or healthcare tech industry.

## Description

Benefits/Perks Highly enriched & healthy work environment Excellent growth opportunities Competitive Pay Career Advancement Job Summary We are seeking an experienced Qual…

 + 9 days ago


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