Job Description Summary # Job Description # # # Be part of something bigger! 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. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. ## About the role: Sr. Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. ## Key responsibilities will include: + Support design control projects + Support the efforts in creation of specifications, design, and test methods for the new products. + Interface with manufacturing on an ongoing basis during the development stages to ensure manufacturability of the design solutions. + Create risk management documentation + Consistent application of technical principles, theories, concepts, and quality sciences / tools. + Proven problem-solving skills + Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements. + Is a team member representing Quality on new product development and sustaining engineering projects. + Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc. + Assists with supplier and internal quality system audits as a means of evaluating the efficiency of the established Quality System and Good manufacturing Practices (Auditor-in-Training) + Support the implementation of new products, processes, and changes by developing quality plans, approval of validation plans and protocols, inspection methods, work instructions, and raw material specifications and inspection plans. + Analyze and interpret inspection and process data to identify and prevent quality problems and continuous improvement opportunities. + Responsible for the investigation, documentation, root cause, and corrective action activities of deviations and non-conforming material. + Responsible for the investigation, documentation, root cause, and corrective action activities of customer complaints. + Conduct Internal and Supplier Audits. Provide audit support for customer and regulatory audits (preparation, closure, etc.) # To be successful in this role: + Extensive knowledge in Design Control principles + Experience in Risk management activities + Proven understanding of statistical concepts such as in measurement system analysis, Gage R&R, and validation + Applied knowledge of applicable regulatory, Corporate and / or Unit requirements. + Experience in design of experiments and statistics + Class II / III medical device experience + Knowledge of six sigma methodology (preferred) + Knowledge of design control principles (preferred) + Typically requires a minimum of a Bachelor’s Degree + A minimum of 5 years meaningful experience or a combination of equivalent education and proven experience. ## Click on Apply if this sounds like you! # Why join us? A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates. ## To learn more about BD visit https://jobs.bd.com/ Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. #LI-PRO # Primary Work LocationUSA UT - Sandy # Additional Locations # Work Shift Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.