Senior Analyst Quality Assurance

Job Description

This position will be primarily responsible for the compliance of Beckman Coulter Bangalore Development Centre Design Control processes to 21 CFR 820, EU Regulation 2017/746, ISO 13485, ISO 9001, MDSAP, Beckman Coulter and Danaher corporate Quality system requirements and to support new product development, risk management and product life cycle management from a Quality and Regulatory Standpoint for IVD and research products. Essential Duties and Responsibilities:
• Ensure management of all design control activities to meet company s business needs, developing company best practices, standards, and continuous improvement, and ensure compliance to regulatory requirements and standards
• Ensures FDA QSR (GMP), EU Regulation 2017/746 (IVDR), ISO 13485, ISO 9001, MDSAP and/or other national or international standards are continuously met with respect to design control and risk management activities
• Develop and implement comprehensive Quality plans for new product development and design changes
• Ensures Design History Files are adequately prepared and maintained
• Supports external audits and inspections as SME for design control processes.
• Supports conduct of Quality System Management Review meetings by ensuring comprehensive analysis of Quality System data and identifying root cause and improvements
Education and/or Experience:
• Master s degree in science, medical or technical field and 9+ years experience with increasing responsibility in Quality and Regulatory Affairs
• Prior experience in Design Quality Assurance and Risk Management is required.
• Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable
• Demonstrable understanding of at least some of the domestic and international quality systems and other standards such as Indian Medical Devices Rule, 2017, FDA QSR, IVDR, MDSAP, SFDA, JPAL, ISO 13485, ISO 14971 or other applicable standards and regulations
Preferred Requirements:
• Experience working with medical device quality systems in compliance with US FDA regulations (21 CFR), EU regulation 2017/746 (IVDR) and ISO 13485
• Creation of Technical documentation for submission to FDA/Notified bodies
• Technical understanding of assay development. Knowledge of flow cytometry is highly desirable.
• Knowledge/experience of validation activities involved in design transfer of new products.
• Able to interpret regulatory requirements and establish practical solutions within a dynamic business environment.
• Cross functional experience with products and manufacturing processes to influence change at appropriate levels within the organizationOTHER SKILLS and ABILITIES
• Exceptional communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with customers, cross-functional project teams and regulators
• Ability to drive results, foster teamwork, handle pressure, and provide feedback
• Must be able to demonstrate skills in root cause investigation and problem solving
• Must have critical thinking skills and good judgment working in an independent environment
• Organized and detail-oriented
• High level of initiative, self-motivation and energy.
• Reliable and responsive.
• Customer focused
• High level of integrity
• Goal oriented, interpersonal, self-motivated and team playerPreferred Requirements
• Experience working with medical device quality systems in compliance with US FDA regulations (21 CFR) and ISO 13485
• Experience in leading continuous improvement efforts, in both quality systems and products.
• Track record for successfully driving multi-faceted cross functional projects, including CAPA projects.
• Cross functional experience with products and manufacturing processes to influence change at all levels within the organization
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Keyskills :
customer relationsreportingbasisaccountsresearchproduct life cycle managementproduct life cyclein vitro diagnosticsnew product developmentdanaher business system