(Urgent Search) Senior Quality Assurance

Summary About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery diagnostics and the delivery of care The company develops innovative technology services and solutions that help advance both clinical therapy for patients and clinical process for health care providers BD has 70 000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues About BD TCI BD a 125-year-old global medical device company has started its Enterprise Center in Bangalore India called BD Technology Campus India TCI This Enterprise Center will be an integral part of the global network for BDX It will have presence of R D Quality Regulatory IT and other functions The center boasts of some of the brightest minds who work in a unique environment that fosters and supports ingenuity BD TCI is dedicated to serving BD s customers and patients thereby contributing its bit towards advancing the world of health Job Summary We are seeking a skilled Senior Quality Assurance Data Analyst to join our Quality team The ideal candidate will have a strong background in digitizing processes and developing innovative solutions with experience in the medical device industry being a plus This role involves collecting analyzing and interpreting complex data to support decision-making and improve operational efficiency Additionally the candidate will perform QA activities to ensure compliance with applicable standards and medical device regulatory requirements Key responsibilities include contributing to the completion of specific programs and projects usually under the direction of a project leader The candidate must have an excellent understanding of applicable standards regulations and industry practices along with strong auditing skills Working under general direction the candidate will independently determine and develop approaches to solutions maintaining frequent inter-organization contacts to achieve stated objectives Job Responsibilities Primary Duties Roles and or Authorities Quality Systems QS Activities Lead QS activities ensuring regulatory compliance for all aspects of QS processes Lead internal audit programs and preparation of Quality Management Review materials Plan and schedule QMS activities ensuring timely completion of action items Lead third-party quality audits manage documentation and close the loop with external auditors Author review and provide input for QS documents to ensure compliance with QSR ISO and EN requirements Understand post-market surveillance and complaint handling processes Provide QS knowledge and administer appropriate training as needed Review and improve existing quality procedure workflows identifying areas for efficiency enhancement Independently author quality investigation reports with appropriate corrective and preventive actions Support internal and external regulatory inspections and audits Train develop and provide relevant technical guidance to cross-functional team members Data Analysis Collect clean and analyze data from various sources to identify trends and insights for Quality systems enhancements Develop and implement data digitization processes to streamline Quality operations Create and maintain dashboards and reports to effectively visualize data and communicate findings to stakeholders Collaborate with cross-functional teams to develop innovative solutions based on data analysis Provide actionable recommendations to improve business processes and drive strategic initiatives Ensure data accuracy and integrity by implementing best practices in data management Education and Experience Education Bachelor s degree in engineering or related discipline Experience Minimum 4 to 6 years of professional experience Knowledge and Skills Good working knowledge and auditing experience of medical device regulations and practices ISO13485 FDA QSR etc Fair understanding of QA principles concepts industry practices and standards General knowledge of related technical disciplines Proven experience in digitizing processes and developing innovative solutions Strong analytical skills with the ability to interpret complex data sets Proficiency in data visualization tools e g Tableau Power BI and statistical software e g Minitab R Python Excellent communication skills to present findings and recommendations effectively Experience in the medical device industry is a plus Ability to work independently and collaboratively in a fast-paced environment Additional Skills Not essential but will be an advantage Certified as a ISO13485 Lead Auditor Trained on 21CFR 820 requirements and ISO14971 Required Skills Optional Skills Primary Work Location IND Bengaluru - Technology Campus Additional Locations Work Shift