Quality Executive(Surgical Industry)
2 months ago
Implementation and improvement in Quality Management System as per ISO 13485:2016.
- Implementation & Formation of Standard Operating Procedure (SOP) & Protocols as per GMP.
- Maintain complete documents of various departments like Site Master File, Device Master File
with easy archival/retrieval.
- Involve onsite into the calibration & Validation activities. Preparation of Calibration calendar and
preventive maintenance.
- Assist in preparation of Batch Manufacturing Record as per manufacturing and their review
before release of the batch.
- Giving line clearance before starting the New Batch.
- Review and analysis of Environmental Monitoring plan to monitor environmental condition and
hygiene of Personnel working in manufacturing areas and other controlled areas.
- Experience of CE, ISO 13485:2016 and GMP Inspections.
- Experience of Risk Management as per ISO 14971
- Experience of Design & development file as per ISO 13485:2016
- Knowledge of Post Market Surveillance and Post Market Clinical Follow Up, Product recall
- Handling and handling market complaints as per SOP and maintaining its records.
Education
- UG: B Tech in Mechanical, BE - Bio Medical, B. Pharma, B. Tech Medical Science
**Experience**:
- total work: 3 years (preferred)
Work Location: In person
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