Gerente de Calidad Sr EMI

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

1. Support development and maintenance of the plant strategic quality and compliance plans and policies.
2. Accountable for the effective execution of processes carried out under departmental leaders (Quality Engineering, Quality Assurance, Quality Control), by prioritizing and managing people, resources, and budget to accomplish expected requirements and performance.
3. Engage and provide leadership directions/objectives, coaching and personal development of site's Quality associates to perform to their best ability and meet both personal and plant objectives.
4. Define framework for department objectives, operation schedule, processes, and budgets.
5. As needed, Act as the plant "management representative" for notified bodies and liaison with regulatory authorities and customers, by hosting and managing related audits and ensuring effective resolution.
6. Build an influential and effective network and communication with WW Quality and Regulatory functions, other plant Quality Leaders and other key WW functions (R&D, Design Assurance, Post Market Surveillance, Engineering, Supply Chain, WW Operations and Manufacturing, etc.) to ensure alignment around global and local priorities.
7. Build an influential and effective network and communication with plant leadership team members in driving overall plant performance relying on a strong culture of Quality and Continuous Improvement.
8. Accountable to successfully manage and communicate quality issues.
9. Accountable for identifying quality improvement opportunities within operations and partnering with peers in Engineering & Manufacturing and from other sites to develop and implement solutions, propose and implement new processes and technologies as alternatives to optimize efficiencies in the departments.
10. Ensure that site quality organization is staffed, organized, and resourced to ensure it can fulfill its obligations to comply with US & global regulatory requirements and BD procedures.
11. Develop a cohesive team, maintaining and reinforcing a strong quality presence in the manufacturing areas, encouraging positive relationships and networking effectively across sites and organizations.
12. Manage performance issues and solicit the appropriate input from HR, stakeholders and management, write and administer performance appraisals on time and in a thorough and thoughtful manner.
13. Manage overall operational leadership in planning and management of quality systems activities, including resource management, which includes the following: Validation program, Internal and external compliance / quality audits, Non-conforming material, Corrective and preventive action program (CAPA board), GMP training program, Quality engineering, Process and Product Change Control, Document Control, Complaint management.
14. Implement corporate Quality policies ensuring finished products conform to company standards and satisfy GMP regulations.
15. Interface with external customers/agencies and FDA during audits and inspections.
16. Other duties as assigned.

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.

Required Skills

Optional Skills

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Primary Work Location

MEX Tijuana - Parque Sur

Additional Locations

Work Shift