职位描述

Ensure testing of raw materials, packing materials, and finished products adheres strictly to standard operating procedures (SOPs).
Maintain device history records (DHR) and product release checklists for each production lot.
Conduct inspections during in-process and incoming stages, as well as complete final product inspections.
Prepare technical documentation such as Device Master Records (DMR) and Device History Records (DHR).
Maintain microbial records in compliance with ISO class-7 and class-8 procedures.
Create master documents to track calibration schedules and ensure the latest version control for documents and records.
Develop control plans, Failure Modes and Effects Analysis (FMEA), and First Article Inspection Report (FAIR) documents.
Compile 8D problem-solving reports and supplier Corrective and Preventive Action (CAPA) documentation.
Oversee calibration activities and perform metrology assessments including drawing reviews.
Lead investigations involving root cause analysis and coordinate corrective actions.

Proficiency with metrology instruments such as Vision Measuring Systems (VMS), Coordinate Measuring Machine (CMM) programming, vernier calipers, micrometers, and height gauges.
Experience with product and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Knowledge of statistical analysis methods including Gauge Repeatability and Reproducibility (Gauge R&R), CpK, PpK studies, Measurement Systems Analysis (MSA), and run charts.
Familiarity with ISO 13485 and ISO 9001 quality management standards.
Expertise in FAIR inspections, document control, and maintaining Device History Records.

Strong technical acumen, analytical capabilities, and effective troubleshooting skills are essential for this role.

Use of VMS, CMM, vernier calipers, micrometers, height gauges, and Minitab statistical software is required.

Quality Engineer