Assistant Quality Engineer

Working knowledge of measuring devices like vision Measurement System, Co-ordinate Measuring Machine, Video Measurement Machine, Digital Caliper, Micrometer, Height Gauge etc.. 2.

Reviewing of product requirements and specifications such as drawings. 3.

Preparing inspection plans, performing metrology activities and preparing FAI reports. 4.

Participating in FMEA / Control plan reviews and preparing FAI reports. 5.

Conducting the measurement system analysis (Gage R&R and attribute agreement studies). 6.

Issuance and retrieval of documents per control of documents procedure. 7.

Maintaining the calibration status of the measuring equipment by periodical tracking. 8.

Inspection of incoming raw materials, buyouts & packing materials per receiving quality plans. 9.

Issuing supplier corrective actions requests (SCAR) and controlling the supplier non conformities. 10.

Performing particle count testes & monitoring of bioburden tests for control of cleanrooms. 11.

Performing final inspections of pecked finished goods for product release. 12.

Inspection of products at start-up, in-process & end-up stages of production. 13.

Maintaining the manufacturing and inspection records in device history records (DHR). 14.

Participating in the investigation of nonconformities, such as root cause analysis. 15.

Preparing 8D report and implementing the corrective and preventive actions. 16.

Identifying & retaining the records per control of records procedure. 17.

Knowledge in programming of CMM & VMM inspection software and associated experience. 18.

Knowledge in the process qualification requirements (IQ, OQ & PQ) & experience in validation. 19 Experience in the use of tools of Minitab software such as measurement system analysis (Gage R&R and attribute agreement studies), process capability studies (CpK & PpK),etc.. 20.

Working knowledge & experience in implementation of the ISO 13485 standard. #IND #LI-JB1