Quality Specialist - Manufacturing

Position Title : Quality Specialist

Position Type : Permanent

Job Summary :

The Quality Specialist will work closely with Management and the Operations team at the company headquarters located in the Westmoreland Business and Research Park, Upper Burrell Township, PA. They will be involved in maintaining a "Current Good Manufacturing Practice" (cGMP) compliant Quality Management System for a Medical Device manufacturer's implemented systems, processes, equipment and materials compliance to ensure the Quality System is established and maintained in accordance with FDA 21 CFR 820, cGMP, MDR 2017 / 745, and ISO 13485 requirements.

Primary Responsibilities :

• Support Quality Management Systems Operations within the organization
• Track, document, and report any changes in, or improvements to, the Quality System
• Involvement in quality processes, products, device history records, inspection, and personnel in all production areas regularly to ensure compliance
• Perform trend analysis on production and field data
• Investigate and document any problems relating to the product, process, or Quality System
• Initiate, recommend, and provide solutions to quality system
• Create or modify existing procedures used in the production facility
• Create and track change notifications on changes made to the system
• Inform and influence workers on improvements and corrections
• Participate in audits from the Food and Drug Administration (FDA), CE, and customers
• Participate in internal auditing practices
• Other Quality System related duties as assigned by Management

Requirements :

SSEIND