over 1 year ago
Senior Quality Engineer
Manage Manufacturing Quality operations in a dynamic, fast paced medical device manufacturing environment. This environment includes the manufacture, inspection, and test of devices for design verification, design validation, and devices to be used in human subject clinical trials. The position reports to the Quality Manager.
- Develop inspection processes and sampling plans according to the risk level of the components, material and devices
- Review existing inspection procedures and sampling plans for continuous improvement and improved workflow
- Provide guidance and assistance on manufacturing processes for new and existing manufacturing lines
- Review Device History Record process and ensure tracking and configuration is maintained prior to shipment
- Participate in Material Review Board (MRB) meetings and follow through with issues
- Participate in ISO 13485 audits and assist in FDA and other regulatory inspections
- Candidate must have a B.A or B.S. in relevant technical field
- At least 5 years’ experience and/or training in Medical Device field is preferred
- QSR Part 820 and ISO 13485 experience preferred
Some clients require proof that temporary associates have received all required doses of the COVID-19 vaccine by their first date of employment, unless a reasonable accommodation recognized by law is approved. To request an accommodation, please email firstname.lastname@example.org.