Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
Sr. Quality Assurance Engineer leads quality initiatives, develops test methods, and ensures compliance with ISO/FDA standards. Drives root cause analysis, CAPA, and continuous improvement in manufacturing processes.Supports new product introductions and validation at all levels.
Job Description
P3-11554
Job Summary
The Sr. QA Engineer:
- Develops methods and metrics for Key Quality Indicators.
- Analyzes data and distributes reports to internal departments and BD divisions.
- Leads quality documentation, records management, and electronic data control.
- Drives training and awareness in quality procedures.
- Leads root cause analysis and CAPA (Corrective and Preventive Actions).
- Implements continuous improvement programs to reduce defects and risks.
- Participates in test method development, new product development, complaint handling, and change control.
- Supports compliance with ISO, FDA, and corporate standards.
- Leads quality aspects of new product introductions.
Job Responsibilities
- Provides technical guidance to QA Engineers/Technicians.
- Participates in A3 creation for Quality.
- Applies intermediate statistical methods (e.g., regression, ANOVA).
- Manages non-conforming product disposition and MRB actions.
- Designs quality studies and reports.
- Approves/supports validation protocols (IQ/OQ/PQ).
- Acts as SME for process/test method validations.
- Leads CAPA assessments and improvements.
- Develops sampling plans and understands OC curves.
- Handles customer complaint evaluations.
- Leads Nonconformance (NC) processes.
- Develops Control Plans and Test Methods.
- Acts as Initial Impact Assessment (IIA) Approver in PegaSystems Change Control.
Knowledge & Skills
- Familiarity with ISO 13485, FDA regulations.
- Certified Quality Engineer (preferred).
- Proficient in quality tools and statistical techniques.
- Experience in root cause analysis, test method development, and process validation.
- Strong English communication skills (oral and written).
- Leadership and team supervision experience.
Required Skills
Optional Skills
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Primary Work Location
MEX Juarez HomecareAdditional Locations
MEX Juarez HealthcareWork Shift
Success Profile
What makes a successful Engineer Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Collaborative
- Conceptual
- Creative
- Imaginative
- Problem-solver
- Team player