Overview
Project Specialist – Finance SOX & Quality Assurance Jobs in United States at Con Edison Company of New York
We are partnering with a leading medical device manufacturer based in Norcross, Georgia, seeking an experienced QA Specialist to join their growing team. This is an exciting opportunity for someone with a strong background in Quality Assurance (QA) or Regulatory Affairs within an FDA-regulated industry.
Job Summary
As a QA Specialist, you will play a crucial role in overseeing Quality Assurance activities and ensuring compliance with FDA regulations, ISO standards, and internal company requirements. You’ll also manage all Document Control functions and contribute to the electronic QMS system.
Responsibilities
Document Control: Final review and sign-off of new documents and revisions before distribution.
Complaint Management: Track and manage product information, recalls, and complaint investigations.
CAPA Management: Oversee the Corrective and Preventive Action (CAPA) process, ensuring timely action and regulatory compliance.
Vendor Management: Maintain the Approved Vendor List, ensuring compliance with internal and regulatory standards.
Audit Support: Assist with internal audits and compliance assessments.
Electronic QMS: Act as System Coordinator for the electronic Quality Management System (QMS).
Training: Maintain and promote company-wide training on Quality Systems and regulatory compliance.
Nonconformance: Track and manage Nonconformance Reports (NCRs), ensuring timely and effective resolution.
Facilities & Equipment: Support compliance for equipment, calibration, and validation activities.
Other duties as assigned by the Director of Regulatory & Quality Affairs.
About You
Qualifications: Bachelor’s Degree required.
Experience: Minimum of 5 years in Quality Assurance or Regulatory Affairs within an FDA-regulated industry.
Skills: Strong understanding of FDA and international regulations, and ISO standards for medical devices.
Job Type: Full-time
Pay: $100,000.00 – $120,000.00 per year
Work Location: In person
Title: Project Specialist – Finance SOX & Quality Assurance
Company: Con Edison Company of New York
Location: United States
