Engineer II, Quality Engineering

Job Description

Job Description SummaryBecton Dickinson, a global medical technology company focused on addressing many of the worlds most pressing and evolving health needs. We have an immediate opening for a highly motivated, results-focused professional to join our team, and are adding to our staff as a Quality Engineer. The Quality Engineers primary responsibilities are to support new product development activities, maintain compliance to company procedures and external standards, manage design history files, review verification and validation documentation, participate in risk analysis activities, collaborate on product development deliverable documentation and support the creation of 510k packages. Responsibilities also include being the quality and compliance representative in the assigned teams. Job DescriptionWho We Are: BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare sector. 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.We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position, you see is right for you, we encourage you to apply!Our people make all the difference in our success.Job DescriptionResponsibilities

• Responsible for being the prime quality representative for design control projects new product development as well as sustaining efforts.
• Provide clarification and guidance to teams on overall quality system with emphasis in design controls.
• Responsible for review and/or approval of design history file documentation in support of design controls.
• Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support.
• Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release.
• Works together with SW Quality Engineers to ensure effective verification of design specifications and requirements.
• Active participant in the development of product requirement, product system hazard analysis and design reviews.
• Reviews and approves Change Orders and/or Electronic Release Authorizations for new releases or design enhancements.
• Identifies areas requiring quality improvement and initiates and follows through plans of action necessary for implementation.
• Ensure product technical files and Design History Files are complete and auditable.

What is expected of you for success in your role

• Communicates effectively with cross-functional teams to execute team s objectives.
• Excellent organizational skills to effectively manage projects in parallel.
• Ability to quickly learn, understand and comprehend highly technical concepts.
• Uses analytical thinking and reasoning to anticipate implication/conclusions of a complex situation or issue.
• Applies understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work
• Good understanding of Agile, design controls and risk management methodologies.
• Teamwork oriented and ability to lead and influence without authority
• Able to work with minimum supervision.

Qualifications

• Bachelors degree in engineering, life sciences or Quality Management.
• 7 years related experience in design and development.
• ASQ certified (CQA, CQE, CSQE, CMQ) is a definite plus
• Must be able to apply quality principles (ISO, 21 CFR, etc.) to the R&D environment
• Knowledge of software development life cycle and test methodology.
• Experience dealing with SW only products highly desired

Culture and Benefits:Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority.Primary Work LocationIND Chandigarh - DLF IT Park Additional LocationsWork Shift,

Keyskills :
inspectionqualityquality controlsoftware development life cyclenew product developmentverificationvalidationrisk analysischange ordersdesign controlquality systemrisk managementhazard analysistechnical files