Quality Engineer

Description

Key Accountabilities/Essential Functions:

To ensure Raw Material / Packing Material and finished goods testing in line with the SOPs.
To maintain device history records (DHR) & product release checklist for each lot.
To conduct inspections at in-process, in-coming and completes the final inspections.
To prepare technical documents like DMR & DHR.
To maintain microbial record in ISO class-7 & class-8 as per procedure.
Creating master documents to track calibration & latest version of documents and records.
To prepare control plan, FMEA & FAIR documents.
To prepare 8D and supplier CAPA reports.
Monitoring calibration activities.
Perform metrology activities & drawing reviews.
Coordinates investigation, root cause analysis & corrective action.

Technical/Functional Skill Sets:

Preferred skills in various metrology equipment, such as VMS, CMM programming, etc.
Product & process validation requirements & implementation.
Gauge R&R, CpK, PpK studies, IQ, OQ,PQ validation/qualification, MSA, run charts, etc.
Working knowledge of the ISO 13485 & ISO 9001standards.
FAIR inspection, DHR & control of documents.

Personal Qualities/Characteristics required for the position:

Good technical, analytical and trouble shooting skills.

Equipment Used:

VMS, CMM, Vernier caliper, micrometer, height gauge, etc.
Minitab software.