Quality Engineer Job in Latrobe 15650, Pennsylvania US
Classic Industries, Inc. is a privately owned manufacturer of medical device sub-components with locations in Latrobe, PA- El Paso, TX- Ponce, PR. Primary manufacturing operations throughout all the facilities are injection molding and pad printing. We are currently seeking a qualified Quality Assurance Engineer to join our Quality Assurance group located in Latrobe, PA.
This position will need to understand the customers’ expectations from new product development to fulfillment of production requirements. They will need to communicate the customer’s expectations to appropriate personnel. Since Classic Industries makes medical components, this position will need to assure company compliance to ISO and Customer standards.
The successful candidate within this position will be responsible for Validation, Change Request, and Quality Systems. They will need to understand critical issues and ensure proper validation of those issues. The QA Engineer will need to facilitate and approve change requests and supporting data. They will also need to facilitate customer and 3rd party audits, review the findings, and make recommendations.
A successful candidate will have five years experience-preferably within plastic injection mold or medical device operations. The candidate will also need a strong understanding of ISO 9001 and ISO 13485 regulations. A Bachelors degree in Engineering or a related field is required. One could expect up to 20% of travel within this role.
NO AGENCY/RECRUITER SOLICITATIONS.