Job Summary
Reporting to the Sr. Quality Engineer, the Quality Assurance Specialist will be responsible for maintaining the Quality Systems for NCRs, CAPA, Complaint handling and Supplier Management following FDA and ISO 13485 regulatory requirements. The Specialist will monitor daily Manufacturing and QC activities to insure compliance with cGMP and the Quality Management System.

Supervisory Responsibilities:
• None

• Maintenance of NCR system, including logging, tracking, implementation of Corrective Actions and effectiveness monitoring
• Conduct training associated with implementation of Corrective Actions
• Maintenance of CAPA system, including logging, tracking and effectiveness monitoring.
• Maintenance of Complaint handling system, including complaint logging and record creation.
• Conduct Internal and Supplier audits
• Prepare Supplier Agreements and maintain Supplier files as directed by Production Manager
• Maintenance of QC Inspection procedures and records.
• Creation and maintenance of Incoming Inspection documentation.
• Participate in product labeling activities including label preparation in compliance with UDI.
• Management of document control, including document revision and record maintenance
• Conduct cGMP and ISO13485 compliance training of Manufacturing and QC
• Manage and maintain Training Matrix and Records
• Assist Office Admin duties as needed.
• Responsible for Regulatory Compliance and applicable International/ National Standards compliance
• Additional responsibilities can be added as required.

Required Skills/Abilities:
• Strong working knowledge of cGMP/ ISO 13485 / FDA 21CFR820 is required.
• Strong working knowledge of MS Excel and Word are essential.
• Knowledge of MS Access preferred. Auditing experience is preferred.
• Apply a risk based approached per ISO 14971 to all applicable elements of the Quality Management System.

Education and Experience:
• BS degree in a technical field or equivalent.
• 1-3 years of work experience in medical manufacturing in a quality role is required.

Physical Requirements:
• Prolonged periods standing and walking.
• Able to bend, stretch, push, pull, crawl and move

Contact Karen Giannone if interested, or if you need more information.