Senior Quality Engineer (Hybrid)

Job Description Summary The Sr. Quality Engineer is accountable for supporting sustaining engineering projects which support strategic and business priorities and initiatives. This person will handle projects and tasks for sustaining product lifecycle and play an active role in the process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of healthâ„¢ is our Purpose, and it's no small feat. It takes the creativity and passion of all of us"”from design and engineering to the manufacturing and marketing of our billions of MedTech products per year"”to look at the impossible and find bold solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Summary: The Sr. Quality Engineer is accountable for supporting sustaining engineering projects which support strategic and business priorities and initiatives. This person will handle projects and tasks for sustaining product lifecycle and play an active role in the process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements. Job Responsibilities: Consistent application of technical principles, theories, concepts, techniques, and quality sciences/tools. Confirmed problem-solving skills. Makes measurable improvements to BD processes and procedures. Ensures that all design control and production/process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements. Acts as a team member representing Quality on sustaining engineering projects which support strategic and business priorities and initiatives. Reviews and has Quality Engineering approval authority for new and modified design/process specifications including product performance specification, test methods, etc. Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and good manufacturing practices (Auditor-in-training). May perform other duties as required. Travel: Up to 25% of the time. Education and Experience: Typically requires a minimum of a bachelor's degree in science, engineering, or other relevant field and a minimum of 5 years relevant experience or a combination of equivalent education and relevant experience. Knowledge and Skills: Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products. Applied knowledge of Corporate and/or Unit requirement. Able to contribute to the completion of specific programs and projects. Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers. Able to revise policies and procedures Able to make presentations Can independently resolve and develop approach to solutions. Able to provide guidance and work direction to lower level project developers. Can design and perform development working independently within defined parameters with minimal supervision required. Experience with BD software systems applied in the Quality Systems is desirable. Must have knowledge/specialization in one or more of the following areas: Acceptance sampling theory and application Statistical process control methods and application Measurement system/test method knowledge and analysis Quality planning Failure analysis investigation Design of Experiments Process mapping and value stream analysis Hypothesis testing Descriptive statistics Process capability analysis Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc. Risk Management Supplier quality management Auditing Design/development tools Process validation Software validation For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit 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. Primary Work Location USA NJ - Franklin Lakes 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.

Created: 2024-10-30