New Kensington, PA
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.
- 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