Quality Specialist Pittsburgh, PA Posted: 8/27/2021
Permanent Full Time
Technical Solutions Inc. is currently seeking a Quality Specialist on behalf of our client, a Pittsburgh area manufacturer of medical devices. The Quality Specialist will work closely with Management and the Operations team at the company headquarters. 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.
*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, and personnel in all production areas regularly to ensure compliance
*Perform trend analysis on production 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 client customers
*Participate in internal auditing practices
*Other Quality System related duties as assigned by Management
*Four-year bachelor"s degree from an accredited university
*Preferred minimum of two (2) years of experience in a regulated medical device setting 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
Technical Solutions Inc. provides a wide range of staffing services throughout Western Pennsylvania, Ohio and West Virginia. Simplify the job search process by letting us do all the work! With 30 years of expertise, we have the resources, techniques and insights to guide your job search. Our staff will work with you one-on-one to understand your needs and discuss your options. We can even send your resume to multiple job openings that you are a fit for, giving you opportunities to choose from. We reach out to hiring managers for feedback, coordinate and schedule interviews, and advocate on your behalf so that you get the best offer possible. At TSI, we genuinely care about our employees and want to see you succeed. No candidate is ever promised something we do not deliver. The best part is that there are no fees or cost for any of our services. For more information on our company and to view all of our exciting job opportunities, please visit www.tsiwork.com or give us a call at 724-733-2100.