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The Quality Engineer II (Validation) ensures compliance with quality policies by executing equipment and process validation, collaborating with quality management, operations, and suppliers. Requires expertise in ISO 13485 and experience in Quality Assurance, Validation (IQ, OQ, PQ), and nonconformance management for regulated devices.
Job Responsibility:
Conduct equipment and process validation, including protocols, reports, and data analysis
Maintain and support equipment validation, calibration, and preventive maintenance
Execute IQ, OQ, PQ for manufacturing equipment
Update FMEA and risk documents as needed
Support QA inspections and document approvals during process relocations
Requirements:
3–5 years in Medical Device, Biotech, or Pharma industries (for QE II)
5–7 years in similar fields (for Sr. QE)
BS in Biological Sciences, Chemistry, Bio-tech Engineering, Bio-engineering, or related fields
Strong verbal and written communication, including technical document writing
Knowledge of quality systems and methodologies
Basic statistical analysis skills (e.g., Minitab or Excel)
In-depth knowledge of process and equipment validation
Experience with Six Sigma methodology
Familiarity with SAP and equipment management systems like BMRAM
Ability to work both independently and collaboratively with minimal supervision