Quality Compliance Specialist

Jersey City, New Jersey

Employer: System One Holdings, LLC
Industry: 
Salary: Competitive
Job type: Full-Time
Title: QC Associate

Location: Jersey City, NJ

Hours: Monday- Friday 9am - 5:30pm

Type: Direct Hire

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:
  • Bachelors in Biology or related field
  • Minimum 3 years' experience in the medical device or pharmaceutical industry
  • Good organizational skills
  • Verbal and written communication skills
  • Experience with ISO 13485 and MDSAP, Internal Audits, Change Controls, Suppliers and familiar with using CAPA systems in a medical device environment.
  • Experience in this industry is required
  • Comfortable working in a constantly changing environment
Created: 2024-09-06
Reference: 325798
Country: United States
State: New Jersey
City: Jersey City
ZIP: 07310

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