09 oct
|
Bd
|
Ciudad Juárez
We are the people who give possibilities purpose
BD is one of the largest integral medical technology companies in the world. Advancing the world of health™ 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.
Job Description
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
· ASQ-CQE certification is desirable.
· Lean Six Sigma Green Belt certification or higher is desirable
Main Responsibilities
· 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
📌 Quality Engineering Manager (Ciudad Juárez)
🏢 Bd
📍 Ciudad Juárez