Job Title

Below are the roles and responsibilities: Quality Management System:Ensure & Support that quality system requirements are effectively established and maintained in accordance with all applicable medical device regulations, preferably including ISO 13485, 21 CFR Part 820 (Current Good Manufacturing Practice (CGMP) regulations), and other standards. Proficient in understanding, review & align with relevant standard operating procedures as per the current technicalities with respect to QMS and other applicable regulatory requirements. Also ensure compliance of different functional QMS SOPs & Manuals. Proficient in Medical Device Labelling compliance (Including India Specific Requirements). Responsible for Execution of Actions for Nonconformance, CAPA, Change Management; Risk Evaluation and Impact assessment, Internal & External Audits / GAP Analysis (Surveys) – Existing SOP Surveys), Supplier Quality Management & Audits, Preparation and amendments of SOPs, Respective Training & Record Management, KPI Data Sourcing & details preparation for review meets. Understanding of Technical aspect and able to drive investigations in technical manner along with Technical department. Learn and Coordinate with Regional / Global Teams for relevant QMS procedures.Post Market Surveillance:Complaint Handling Process: Should be aware about the Indian guidelines for reporting AE/SAE complaints. Responsible for evaluation and assessment of any complaint/feedback from reporting point of view to authority. Responsible to support RA team to report the SAE/AE to CDSCO or its authorized centre.Recall and FCA Should be aware about the Indian and IMDRF countries guidelines about the Recall and FCA. Responsible for coordination with FSCA stakeholders, complaint assessment monitoring, and management of FSCA/Recall as per timeline and reporting of the same to CDSCO.Non-Conformity / CAPA Should be able to support activities towards reported non-conformities and prepare periodic reports, Hold NRBs and prepare NC details for meets, Learn and execute NC operations over Agile. CAPA management, learn Agile platform for CAPA operation. Hold CRB meets, monthly.Data Upkeepment / Training / Awareness Should be able to support QMS training & Awareness activities including data / record management. Should be able to timely prepare & upkeep key activities details for periodic reviews.Qualifications B. Tech / BME / – B. Pharma / M Pharma / M.Sc Biotechnology - Preferably with PG Diploma / QA and / or Preferred Certification (ISO13485 – Standard / Internal Auditor and/or LA and/or Risk Management (Medical Device) from reputed organization (such as TUV-SuD / BSI).Preferred Experience Minimum 4-7 years of working experience in a customer-oriented position in QA / QMS dept of an international organization, preferably the Medical Equipment / Device company. MS Office (focus Excel), Agile, Argus, etc. Fluent in oral/written communication (English). Preferable work experience on SFDC, EtQ, Track-Wise or Alike portal for execution of complaint initiation and handling.Interested candidates, please mail your resume totaru.arora@.Regards HR Team