This Position Will be responsible for all the aspects of quality assurance, such as implementing testing & inspection procedures, monitoring the quality of products in each stage of production, collecting data; analyzing the test result; maintaining the measuring & monitoring equipment; generating validation reports; control of the nonconforming products, etc.
Preferred Industry- Medical device, healthcare & automobile industry preferably.
Qualitification- Degree/Diploma in Mechanical Engineering is preferred
Experience-2 to 5 Years Preferred
Communication and Presentation Skills-
Equipment Used-Positive communication skills in English (spoken & written).
Working knowledge of measuring devices like Vision Measurement System, Co-ordinate Measuring Machine, Video Measurement Machine, Digital Caliper, Micrometer, Height Gauge, etc..
Key Accountabilities/Essential Functions
Reviewing of product requirements & specifications such as drawings.
- Preparing inspection plans, performing metrology activities and preparing FAI reports.
- Participating in FMEA / Control Plan review and preparing of device master records (DMR).
- Conducting the measurement system analysis (Gage R&R; ans attribute agreement studies).
- Issuance and retrieval of documents per control of documents procedure.
- Maintaining the calibration status of the measuring equipment by periodical tracking.
- Inspection of incoming raw materials,
buyouts & packing materials per receiving quality plans.
- Issuing supplier corrective action requests (SCAR) and controlling the supplier nonconformities.
- Performing particle count tests & monitoring of bioburden tests for control of cleanrooms.
- Inspection of products at start-up, in-process and end-up stages of production.
- Maintaining of the manufacturing and inspection records in device history records (DHR).
- Performing final inspections of packed finished goods for product release.
- Participating in the investigation of non-conformities such as root cause analysis.
- Preparing 8D report and implementing the corrective and preventive actions.
- Identifying and retaining the records per control of records procedure.
Technical/Functional Skill Sets
- Knowledge in programming of CMM & VMM inspection software and associated experience.
- Knowledge in the process qualification requirements (IQ, OQ & PQ) and experience in validation.
- Experience in the use of tools of Minitab software such as measurement system analysis (Gage R&R; & attribute agreement studies), process capability studies (CpK & PpK), etc.
- Working knowledge & experience in implementation of ISO 13485 standard.
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Job Types: Full-time, Permanent
Pay: ₹300,000.00 - ₹400,000.00 per year
Benefits:
- Food provided
- Health insurance
- Provident Fund