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

Responsible for overseeing and ensuring adherence to all relevant quality management systems, compliance and regulatory requirements, and internal policies

Job Responsibilities:**

* Develop, implement, and maintain a robust Quality Management System (QMS).

*Manage team within area. Develop team members to increase business acumen and functional skills

*Identify complex quality issues and support timely resolution 
* Lead and manage internal and external quality audits, including pre-assessment audits, surveillance audits, and certification audits, ensuring timely and effective resolution of findings.
* Oversee the CAPA (Corrective and Preventive Action) system, ensuring thorough investigation of non-conformances, root cause analysis, and effective implementation and verification of corrective and preventive actions.
* Manage the document control system, ensuring all quality-related documents are properly created, reviewed, approved, distributed, and archived.
* Provide guidance and training to all departments on quality compliance matters.
* Collaborate with R&D, manufacturing, and supply chain teams to integrate quality by design principles throughout the product lifecycle, from design and development to production and post-market surveillance.
* Prepare and present quality performance metrics and compliance reports to senior management.
* Facilitate regulatory submissions and interactions with other sites regulatory bodies, co as required.

Job Qualifications:**

* Bachelor's degree in engineering, Life Sciences, or a related technical field. Master's degree preferred.
* Extensive knowledge and practical experience with ISO 13485, FDA 21 CFR Part 820, MDR (EU 2017/745), and other relevant international medical device regulations.
* Proven experience in managing QMS, CAPA, document control, and audit processes.
* Certified Lead Auditor (e.g., ISO 13485) strongly preferred.
* Strong analytical, problem-solving, and decision-making skills.
* Excellent written and verbal communication skills in English and Spanish.
* Ability to work independently and collaboratively in a fast-paced environment.
* Proficiency in quality management software and tools.
* Strong leadership and interpersonal skills with the ability to influence and motivate cross-functional teams.

*Time management and prioritizing skills

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visithttps://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.

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