Quality Assurance Executive Job in Siora Surgicals Private Limited

Job Description:

• Create and maintain company quality documentation, such as manuals, procedures, etc.
• Continuously improve QA processes and procedures.
• The Preparation of QA reports.
• Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012

Industry: Medical Devices/ Equipment

Functional Area: Quality Assurance

Employment Type: Permanent Job, Full Time

Desired Candidate Profile

• 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 Implementation and improvement in Quality Management System as per ISO 13485:2016.

  Company Profile:

  One of the leading manufacturers and suppliers of Orthopedic Implants and instruments, founded in 1987 and having a manufacturing unit at Rai Industrial Area, District Sonipat, Haryana, and Corporate Office in Phool Bagh, Rampura, New Delhi Near Ashok Park Main Metro Station.

  Note: Kindly mail your resume at [email protected]. Our HR team will call you for the interview if your resume is selected.