Engineer-Quality Assurance &
PERFINT HEALTHCARE PRIVATE LTD
- To perform assigned QA functions to ensure facility compliance with the Company’s Quality Policy and all applicable external standards and regulatory requirements.
- Help execute and maintain (keep up-to-date) the Company’s Quality System (QS) and related records per current FDA cGMP regulations and the ISO 13485 standard.
- Corrective and Preventive Action (CAPA), Complaint Handling, Document/Change control, Supplier control, Post-market Surveillance and other QA&RA activities.
- Work closely with engineering and manufacturing to assure compliance. Help in providing regulatory guidance to engineering to support design controls and design transfer, acceptance of new products and manufacturing.
- Maintain the Design History Files for US compliance. Maintain the Technical Files, and Declarations of Conformity, for compliance with the European Medical Device Directive.
- Support a Facility/Management Representative to external regulatory agencies.
- Help conduct due diligence internal and external audits to identify all significant QA&RA deficiencies. Ensure the appropriate methods of measurement for detection of quality problems.
- Provide inputs / report on the QS performance for management review. Support and promote company-wide quality improvement efforts for uncompromised reliability and safety.
- Help review and approve device labeling and market literature to ensure regulatory compliance.
- Worked with manufacturing team as a quality coordinator and helped them with training,Audits,dashboard activities and in creating a online module for Non conformance material and Process report.
- Help provide ongoing QA&RA training to our team. Help develop and deliver training modules. Maintain personnel training records.
- Additional responsibilities includes helping Director -Supply chain & Engineering by handling disposables in CE submissions,Working with ETO sterilization service provider, Interacting with testing laboratories for Biocompatibility testing and ETO sterilization testings, Disposable manufacturing vendor development.
The quality of my performance in this role is also demonstrated by the fact that I received the Special annual award to recognize the efforts & Performance (Year Award for 2014).