Job Id: 20201011037
Job Role: Quality Engineer- Medical Devices
Experience: Relevant Experience
Job Location: Hyderabad
Salary: Best in Industry
Vacancies: Not Mentioned
Job Description Cyient Careers Job Vacancies for Quality Engineer Medical Devices in October 2020:
Complete a post-market PPA for the end items that will be affected by the transfer of the subcomponent. This assess if there are any existing issues with any of the items that need to be resolved prior to the transfer beginning.
a. Review of complaint data and identify any major issues or recurring failure modes that need to be addressed
b. Review of the nonconformance data to identify any open/unresolved nonconformances that need to be addressed
c. Review of the CAPA/SCAPA records to see if there has been any issues, resolved or unresolved, that may affect the end items.
d. Review of MCDRs (Material Control and Disposition Report) to identify if any of the end items have had repeated manufacturing issues where the parts were out of spec and accepted as is, scrapped, or reworked.
Complete Control Characteristic Traceability Matrix for each of the manufacturing transferred components or subcomponents. This involves identifying the critical features (necessary for the product to function) of the subcomponents being transferred. Each of these critical features are given a severity ranking that will determine the level of inspection required during manufacturing.
a. This typically involves working with a manufacturing or concurrent engineer who drafts the Control Characteristic Traceability Matrix based on existing documents.
b. This drafted Control Characteristic Traceability Matrix is reviewed by DQE and PD to ensure all critical features are captured and severities are assigned correctly.
Review Gage R&R’s provided by the team with interfacing team.
The review is to ensure the inspection methods they are using is appropriate and their results are acceptable.
Critical to quality improvement opportunities.
Review CCR at Impact Review and Plan Execution.
Skills & Experience
CAPA System, Materials Control, Post Market, Traceability Matrix