QA/QC RA Manager, Electro Medical Devices, Vapi. ISO, CE

Role & responsibilities :

• ISO 9001/ISO 13485.
• Manage the Quality Management System.
• To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements.
• Risk Management & CAPA.
• Establishing procedures and records as per requirement of standards and regulatory authorities.
• Responsible for establishing, managing, and implementing Records Management policy, Records.
• Retention and retrieval procedures are in place.
• To manage and execute internal and external audit schedules and follow up on action plan,
  Quality Auditing of External suppliers - maintain an annual auditing program.
• Regular Internal Quality Audit and maintain the company anytime audit ready.
  Participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs & NCs.
• To monitor & handle market complaints.
• Conduct Management review at site.
• Conduct Calibration of instrument & Maintain Calibration Matrix .
• Ensure that a respective Change Control procedure is in place and adhered to .
• Process validation protocol preparation & implementation.
• Provide leadership and expertise on all aspects of product regulatory compliance to ensure that products are successfully introduced and maintained domestically and globally pursuant to regulatory compliance.
• Must be capable to handle all types of Audit.
• To Lead and face the regulatory audits and close all queries and NC in stipulated time.
• To maintain all documents related to compliances. Create Maintain & update Device Master/ Product Technical File.

Preferred candidate profile:

• Graduate in Science or Engineering . Post Graduation preferred.
• Thorough Experience in quality and regulatory areas.
• Thorough experience in ISO 13485, GMP, US FDA, EU MDR, CDSCO, ISO 9001.
• Regulatory functions throughout the organization including monitoring , improvement , audits, and team building.
• Thoroughly conversant with technical documentation requirement and preparation.
• Excellent MS office skills.
• Should have faced multiple audits from multiple agencies
• Should have thorough knowledge of the applicable standards

Perks and benefits: Medical Insurance for Spouse , 2 Kids Below 18 years upto Rs. 3lac.