Quality Specialist

New Kensington, PA

Industry: Manufacturing Job Number: Req-4096 Pay Rate: Negotiable

Job Description

A medical device company, located northeast of Pittsburgh, PA, is seeking a temporary Quality Specialist to fill in for an employee on maternity leave.


  • Responsible for maintaining a 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, CE MDD 93/42/EEC, CE MDR 2017/745, and ISO 13485 Regulatory Standards.
  • Involvement in the maintenance and improvement of the Quality system in a medical device manufacturing facility as it pertains to FDA, CE Mark, and related country requirements globally.
  • Develop and modify relevant procedures and work instructions as necessary.
  • Ensure conformance to ISO, CE, FDA and other international/local regulations.
  • Investigate and document issues relating to the product, process, or Quality System relevant to the compliance.
  • Initiate, recommend, and provide solutions to quality system.
  • Document and verify the implementation or correction of solutions to processes, products, and equipment.

Job Requirements


  • Bachelor’s Degree in a related field and a minimum of 2 years of quality experience within a regulated medical manufacturing environment
  • Experience with FDA, cGMP, CE MDD/MDR, MDSAP, and ISO regulatory standards desired
  • Proficient with MS Office
  • Excellent verbal and written communication skills
  • Strong analytical and problem-solving skills along with attention to detail
  • Ability to work in a fast-paced team environment with the ability to manage multiple, simultaneous responsibilities

Hours: Monday-Friday, 8:00am-5:00pm

Meet Your Recruiter

JH Technical Services

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