Required: Experience 3-4 years
Job Summary
As a Quality Assurance , he will be responsible for performing a variety of QA duties to determine if materials, products, and or processes are in accordance with specifications and requirements Roles Validation of process Validation of machines Validation of product Clinical Evaluation Statistical techniques Corrective and Preventive Action CAPA with log MDR procedures with log Non-conformance with log To handle customer complaint with log Maintaining all required records documentation Risk Management.
Responsibilities and Duties
As a Quality Assurance, he will be responsible for performing a variety of QA duties to determine if materials, products, and or processes are in accordance with specifications and requirements Roles Validation of process Validation of machines Validation of product Clinical Evaluation Statistical techniques Corrective and Preventive Action CAPA with log MDR procedures with log Non-conformance with log To handle customer complaint with log Maintaining all required records documentation Risk Management
Conduct internal audit for ISO and CE Certification. Handle External Audit for ISO and CE Certification Implement MDR new regulations in Plant. Must be from Medical Device Company. We are looking for experienced Quality Assurance & Regulatory Affairs to ensure that our products and services meet all necessary requirements before they reach the consumer. The Regulatory Affairs Officer will inspect the final product to make sure it has been built with compliance with legal standards and meets customer expectations. A great Regulatory Affairs Officer is thorough and observant with an eye for detail. They must fully understand the requirements for the product or service and have a sense of responsibility towards our potential and existing customers as well as the competition. The goal is to help preserve our reputation by ensuring that our products and services are capable to drive sustainable growth. Responsibilities:
Understand customer needs and requirements to develop effective quality control processes. Supervise inspectors, technicians and other staff and provide guidance and feedback. Oversee all product development procedures to identify deviations from quality standards. Keep accurate documentation and perform statistical analysis. Be on the lookout for opportunities for improvement and develop new efficient procedures. Knowledge of the Production process of medical device manufacturing (IV Cannula). Implementing and maintaining Quality Management System (QMS), that complies with ISO 13485, ISO 14971 and FDA 21 CFR Part 820, Develop and implement quality control and inspection procedures for receipt and control of incoming materials, in-process materials and final product acceptance activities. Support the quality inspection to ensure, products and processes comply with the relevant requirements of the QMS. Analyze failure, corrective and preventive action to respond to internal/external customer complaints. Manage, coordinate and oversee all validation studies, cleaning validation, change controls, protocol revisions, equipment validation, and documentation of results for manufacturing equipment. Data analysis, continuously improve QA processes and procedures. Establish and maintain test instrument calibration procedures and maintenance schedules. Data and record maintenance according to ISO 13485 & GMP certification. Industry: Medical / Healthcare / Hospitals
Functional Area: Quality Assurance
Role Category: Quality Assurance & Regulatory Affairs
Role: Quality Assurance Regulatory Affairs Manager
