Quality Engineer
Roles & Responsibilities
- 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.
Experience Required
- For QE II: 3–5 years in Medical Device, Biotech, or Pharma industries.
- For Sr. QE: 5–7 years in similar fields.
Skills & Certifications
- 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.
- Organizational skills and multitasking abilities.
Eligibilities & qualifications
- BS in Biological Sciences, Chemistry, Bio-tech Engineering, Bio-engineering, or related fields.
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