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13 Siora Surgicals Jobs
Senior Quality Assurance Executive
Siora Surgicals
posted 4mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Education : UG: B Tech in Mechanical, BE Bio Medical, B. Pharma, B. Tech Medical Science
Key skills: - Thorough Knowledge of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017.
- Create and maintain company quality documentation, such as manuals, procedures, etc.
- Continuously improve QA processes and procedures.
- Preparation of QA reports.
- Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012.
- 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.
Employment Type: Full Time, Permanent
Functional Areas: Other
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What Siora Surgicals employees are saying about work life
based on 27 employees
Flexible timing
Monday to Saturday
No travel
Day Shift
Siora Surgicals Benefits
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