We are the people who give possibilities purpose
BD is one of the largest global 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
The Senior Mgr, Quality Assurance provides strategic leadership and oversight of the site Manufacturing Operations to ensure compliance with the applicable regulations such as: FDA regulations (21 CFR Parts 210, 211, and 820 as applicable), EU GMP, and ISO 13485 standards.
This role is accountable for end-to-end Quality oversight across the manufacturing process of Surgery products. The position supports and oversight contamination control strategy, risk-based decision-making, and sustainable compliance culture, while enabling operational excellence and supply continuity.
The Sr Mgr acts as a key member of the site quality leadership team, driving quality strategy, regulatory readiness, and continuous improvement initiatives aligned with global and site objectives.
Works collaboratively with Manufacturing, Supply Chain, EHS, Engineering, and other cross-functional teams.
Job Responsibilities:
Operations Quality Oversight
- Ensure adherence to cGMP requirements (21 CFR 210/211, 820 as applicable), EU GMP, and ISO standards.
- Provide independent Quality oversight of manufacturing operations, including:
- In-process controls and testing
- Batch record review and approval
- Ensure timely disposition decisions based on sound risk assessment and regulatory requirements.
- Drive increased Quality presence on the shop floor to ensure real-time compliance and issue resolution.
- Ensure production and process controls are aligned with validated states and lifecycle requirements.
- Ensure all investigations, CAPA, deviations, change control, complaints, in your area of responsibility are effectively implemented, sustainable, and inspection-ready.
- Maintain proactive and effective communication with R&D, Design, Regulatory Affairs, and Pharma stakeholders.
Compliance, Risk Management & Continuous Improvement- Drive risk-based decision-making using quality risk management principles.
- Analyze trends across investigations, complaints, and process performance to identify systemic issues and drive improvements.
- Leads the development and documentation of structured, rel="noopener noreferrer">https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.
Required Skills
Optional Skills
.
Primary Work Location
USA TX - El Paso - Northwestern Dr.
Additional Locations
Work Shift
