More jobs:
SW QMS Specialist
Job in
South Plainfield, Middlesex County, New Jersey, 07080, USA
Listed on 2026-10-08
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-10-08
Job specializations:
-
Healthcare
Data Scientist -
Quality Assurance - QA/QC
Job Description & How to Apply Below
24-01951
Job Description:
Qualifications:
• 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. We are seeking a motivated SW QMS Specialist to join Katalyst Health cares & Life Sciences in South Plainfield, NJ, United States. Our group is growing, and we are hiring a SW QMS Specialist in South Plainfield, NJ, United States.
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