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QC Associate

System One Holdings, LLC
Jersey, NJ Full Time
POSTED ON 1/17/2025
AVAILABLE BEFORE 4/7/2025

Job Title : QC Associate

Location : Jersey City, NJ

Type : Direct Hire

Hours : Monday-Friday 9AM-5PM

Job Summary :

Our company is recognized as a certified global leader in medical biotechnologies, specializing in tissue engineering. We are looking for a talented and competitive Quality Compliance Associate who thrives in the medical device industry.

Responsibilities :

  • Initiating and / or managing non-conformities / CAPAs (Corrective Actions / Preventive Actions) and change management forms.
  • Management of distributor and supplier qualifications.
  • Maintain QMS compliant with FDA, ISO13485, and MDSAP requirements.
  • Evaluate performance of QMS.
  • Support R&D Team in design controls records.
  • Supervise internal audit process.
  • Coordinating, monitoring, and managing of quality functions across multiple departments to ensure high level of compliance with industry quality standards.
  • Other duties related to the Quality Management System.

Requirements :

  • Bachelor's in biology or related field
  • Minimum 5 years' experience in the medical device or pharmaceutical industry
  • Good organizational skills
  • Verbal and written communication skills
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