A medical device company, located northeast of Pittsburgh, is seeking a Quality / Regulatory Specialist.
Responsible for maintaining a GMP 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, CE MDD 93/42/EEC, and ISO 13485 regulatory Standards.
Track, document, and report any changes in, or improvements to, the Quality System.
Inspect Production quality processes, products, and personnel in all production areas regularly to ensure compliance.
Investigate and document any problems relating to the product, process, or Quality System.
Initiate, recommend, and provide solutions to quality system problems.
Document and verify the implementation or correction of solutions to processes, products, and equipment.
Schedule and conduct internal and external audits.
Assist in sourcing vendors by vendor qualification.
Qualify Operations personnel on Quality Processes and related information.
Inform and influence workers on improvements and corrections.
Assist in compiling Device Master Records (DMR) and Design History Files (DHF).
Prepare for and conduct audits from the Food and Drug Administration (FDA), CE, and customers.
Some travel may be required either domestically or internationally.
Bachelor’s Degree in a related field and a minimum of 2 years of quality and regulatory experience within a medical manufacturing environment
Must have experience with FDA, cGMP, CE, and ISO regulatory standards
Proficient with MS Office
Excellent verbal and written skills
Ability to work in a fast paced environment with the ability to manage multiple, simultaneous responsibilities
Hours: Monday-Friday, 8:00am-5:00pm
Additional Salary Information: Pay rate depends on experience
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 t...he following: Engineering, Architecture, Information Technology, Construction, Energy, Manufacturing, and Professional/Office. The Right Recruiter. The Right Measurements. The Right Candidates.