BD (Becton, Dickinson and Company) Sr. Engineer QA in Bangalore, India
Job Description Summary
The QA Sr. engineer primary role is ensuring that the R&D center is in full compliance to the BDx quality systems process and design control procedures across BDx. The senior Engineer QA is responsible for developing and implementing the Quality Management strategy for the India Design Center with a major focus on Laboratory management in collaboration with BDx quality leadership. The position is responsible for establishing and sustaining a Quality Management System that complies with applicable standards and regulations and assuring that all BD products are designed and verified utilizing systems which comply with current industry and regulatory standards and conform to customer expectations for safety and effectiveness. This position also provides the oversight and leadership to ensure the laboratory environments are appropriately set up and maintained along the with environmental chambers. This role also provides full support to conduct internal quality audits and external quality audits. The position provides quality engineering leadership, oversight and direction in problem-solving and team-building capabilities.
Develop and implement the Quality Management strategy in collaboration with BDx quality leadership.
Lead the development, sustenance and continual improvement of quality systems complying with 21 CFR 820 and ISO 13485 quality system requirements with a specific focus on design control including defect management.
Should have handled medical device lab related QMS elements like developing calibration procedures, SOPs, EHS elements, equipment management and maintenance procedures, risk management etc.
Execute, measure and report on the progress of the Quality Management strategic initiatives.
Assure that the policies, procedures & systems are designed and implemented to produce products which conform to established quality standards and comply with Industry and Government Standards.
Provide the required Quality Engineering support and promote use of statistical tools in product design and development activities.
Participate and in risk Management activities for products under design authority in compliance with ISO 14971.
Participate in the management review process as the Lab Quality Management Representative.
Assume a leadership role in continuous improvement of current practices to improve quality and worldwide market share.
Support manufacturing sites with appropriate technological and problem-solving skills and resources to prevent and/ or minimize adverse situations.
Develop and continuously improve skills and adequacy of department resources in order to maintain appropriate levels of Quality Assurance.
Develop and apply innovative approaches within the Quality Assurance function.
Continuously apprise Senior Management of the level of quality throughout the center.
Prepare, maintain, and adhere to approved departmental budget.
Masters or bachelor’s degree in Mechanical Engineering or related discipline
Minimum 5 years of progressive experience in Quality Assurance within an FDA regulated industry
Minimum 2 years of experience in independent handling of QA administration and planning experience
Strong understanding of medical device quality assurance
Knowledge and experience in manufacturing and project management desirable
Knowledge of DFSS, Six Sigma and relevant statistical tools(Minitab) supporting design assurance activities
Excellent oral and written communication and technical writing skills, and proven supervisory/ leadership capability and working with multi-disciplinary teams
Experience in management of QE professional and technical staff
Expertise in standards and regulations (ISO 13485, 21 CFR 820, ISO 14971, EU MDR, etc.) affecting medical devices marketed in all regions throughout the world
Entrepreneurial drive and demonstrated ability to achieve stretch goals in an innovative and fast-paced design center environment
Experience of leading internal and external compliance audits
Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)
Experience in high volume manufacturing and assembly processes, particularly those of plastic injection molded parts and assemblies.
Disciplined and well-organized in documentation (plans, requirements, drawings, design reviews, and test methods).
Strong critical thinking, analytical, and problem solving skills.
Certified quality auditor
Primary Work Location
IND Bangalore - Technology Campus
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.