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:
Four year bachelor's degree from an accredited university
Minimum of 2 years of experience in a regulated medical device setting or similar with working knowledge of FDA 21 CFR Part 820 and ISO 13485
Required Computer Software Skills: Microsoft Office Word, Excel, PowerPoint
Good verbal and written skills
Ability to work in a fast-paced environment with the ability to manage multiple, simultaneous responsibilities.
Additional skills: Process Improvement, Analyzing Information, Attention to Detail, Thoroughness, Dealing with complexity and controversy