A medical device company, located northeast of Pittsburgh, PA, is seeking a Quality Specialist.
Responsible for 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.
Track, document, and report any changes in, or improvements to, the Quality System.
Inspect 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 customers.
Participate in internal auditing practices.
Minimal domestic travel will be required for vendor auditing and training.
COVID vaccine will be required for all employees.
Associate’s and/or Bachelor’s Degree in a related field and a minimum of 2 years of quality experience within a regulated medical manufacturing environment
Must have experience with FDA, cGMP, and ISO regulatory standards
Proficient with MS Office Suite
Excellent verbal and written skills
Strong analytical skills along with attention to detail
Ability to work in a fast paced environment with the ability to manage multiple, simultaneous responsibilities
JH Technical Services, Inc. / JH Staffing Services was founded in 1996 and is headquartered in Pittsburgh, PA. JH has become one of the area’s fastest growing and most respected staffing firms, and is focused on assisting both clients and candidates throughout the tri-state area. We offer contract, contract to hire, and permanent placement options. The industries that we specialize in include the following: Engineering, Architecture, Information Technology, Construction, Energy, Manufacturing, and Professional/Office. The Right Recruiter. The Right Measurements. The Right Candidates.