We are the people who give possibilities purpose BD is one of the largest general medical technology companies in the world. Advancing the world of healthTM is our Purpose, and it's no small feat. It takes the imagination 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 transformative solutions that turn dreams into possibilities.
Education and Experience
Bachelor's degree in engineering or equivalent technical degree in sciences (biology, physics, etc.).
Minimum 5 years of experience in a medical device company or in a high-volume regulated manufacturing environment.
Minimum 5 years of experience in Quality Assurance roles with impact on decision-making and/or in supervision/leadership or other related functions
Lead a team of quality engineers to support the entire product lifecycle, ensuring that quality requirements are defined and implemented during the NPI, including design validation, risk management,
and process validation to achieve readiness for commercialization; leading quality activities in product and process transfers ensuring equivalence, validation and alignment with the QMS; provide oversight of support activities through effective change control, performance monitoring, and continuous improvement; maintain compliance with SIB initiatives by managing revalidations and ensuring documentation accuracy and data integrity.
Ensure the proper disposal of non-conforming products, through technical review and approval of disposal decisions (use-as-is, rework, sort, or scrap), ensuring compliance with Quality Management System (QMS) procedures, regulatory requirements and assessment of associated risks.
Plan and coordinate quality engineering activities and resource requirements according to the goals and needs of the plant to meet established KPIs.
Ensure that Quality Engineers support, develop, and review, as appropriate, statistical analy