Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
Job Description Summary
We are the makers of possible
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.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. Leads the Quality function for the BD Interventional Operations Center, Puerto Rico (BOC), with direct responsibility for its three manufacturing sites in Mexico, and as such, the QA heads of those manufacturing sites will report directly to this role, with dotted line to the Plant Manager. The incumbent will serve as a member of the BOC Management Board.
This position is responsible for leading the development, implementation, and continuous improvement of BOC's Quality Systems. You will be responsible for the identification and tracking of appropriate leading quality performance indicators to assess BOC's manufacturing sites performance. You will develop QA strategies in support of the Mexico Plants Quality Plan and the business objectives.
The incumbent has the challenge of ensuring that the products manufactured at the Mexico plants and the quality system deployed by the Mexico Plants are in compliance with BD requirements, FDA regulations, as well as all applicable international regulatory requirements such as European MDD, Japanese PAL, Australian TGA, and ISO 13485 requirements.
The incumbent must be able to function as both an individual contributor and an overall director of activities in a matrixed organization. The incumbent will work closely with plant, Business Units, regions and corporate staff, across multiple functions including regulatory, clinical, R&D, operations, and supply chain.
Essential Duties and Responsibilities:
- Develops quality plans and goals for Mexico BOC manufacturing sites, and interactively monitors and directs performance to same.
- Establishes effective quality procedures for the Mexico plants to ensure compliance with BD, FDA and other applicable global quality system /regulatory requirements, while supporting operational goals.
- Ability to handle a variety of individual projects (i.e. implementing document control software systems, implementing labeling systems, implementing manufacturing best practices, corporate initiatives, etc.), while directing the efforts of direct reports at the same time.
- Communicates to Mexico Plant Management and marketing divisions on the status and performance of Mexico plant products and quality systems.
- As part of the Mexico Plant Management Team, provides marketing divisions with the necessary inputs for design for manufacturability, process failure modes, critical control points as well as participates in the periodic review of projects and new product development reviews. Ensures compliance with design transfer policies.
- Acts as liaison between Mexico plants, Corporate auditors, the FDA, and other international regulatory bodies, during GMP and quality systems audits.
- Organizes periodic reviews of the Mexico plant Quality system to ensure compliance with internal and external requirements.
- Works with the VP of Regulatory Compliance to prepare for, manage and respond to FDA inspections and associated FDA Form 483 observations. Cross-functionally, and in coordination with the associated marketing divisions, oversees the implementation of corrective action plans in response to regulatory inspections.
- Formulates and implements annual department goals, action plans, and budgets according to operational priorities.
- Ensures product failure investigations are conducted thoroughly and that the information is timely submitted to the corresponding marketing divisions to prepare the necessary product remedial actions that finally are submitted to Corporate for final disposition.
- Across all products, ensures appropriate quality metrics are recorded, analyzed and reported regularly to the marketing divisions and Corporate.
- Through effective oversight and personal interaction, leads the Mexico Plant Quality Assurance team to ensure all products manufactured and released for commercial distribution meet BD, FDA and global quality systems requirements for safety and efficacy, and to drive continuous improvement strategies across all products and facilities.
- Accountable for strategic supplier management and decisions across the Mexico plants.
- Attracts, retains and mentors the highest caliber quality assurance, environmental health and safety personnel. Develops staffing requirements and assumes responsibility for planning, recruiting, training and motivating the necessary team members. Ensures bench strength and succession planning through appropriate recruiting, staffing and development of team members.
- Provides guidance and advises on complex compliance issues in the Mexico Plants with expected impact on BD as a whole. Maintains active involvement in medical device and quality assurance associations to ensure the company remains current on the industry, and trends and regulations.
- Maintains active Quality Management processes for the Mexico Plants and their manufacturing sites including both the CAPA and Management Review Systems, in compliance with Company Standards.
- Works effectively with a variety of people including suppliers, inventors, corporate officers and staff, medical and technical professionals, FDA, Notified Bodies, and other regulatory agencies.
- Must follow and comply with company policies and procedures, as applicable in the role.
Education and/ or Experience Required:
- B.S. degree in Engineering, Microbiology, Chemistry or related scientific field required. M.S., M.B.A., or advanced degree highly recommended.
- 15 years' experience in managing Quality Assurance programs in the medical device field.
- Fluency in speaking Spanish is strongly preferred in order to effectively communicate quality goals, objectives, expectations, and to discuss key quality issues in order to reach/interact with all Mexico Plant Spanish speaking personnel.
- Experience in complying with, and managing, FDA audits and other global governing agency audits as they relate to developing, manufacturing and distributing medical devices and surgical products both in the United States and throughout the world.
Additional Desirable Skills and Knowledge:
Core Competencies: To perform this job successfully, an individual must be able to perform each essential duty satisfactory. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Working knowledge of US and International regulations governing the medical device industry, i.e., GMP, GLPs, MDR, and ISO 13485.
- Ten (10) years' experience successfully managing quality across multiple FDA & Notified Body audited manufacturing plants, one of which must be a large (greater than 500 employees) manufacturing plant.
- Strong managerial skills and ability to manage multiple departmental budgets.
- Excellent communication skills (verbal and written), and problem-solving skills.
- Knowledge of fundamental quality engineering principles such as Process Validation, Design of Experiments, and Process Control & Capability.
- Well-schooled in matrix management and able to work collaboratively cross-functionally as well as across business units.
- A person of strong conviction with effective persuasion skills, must be comfortable making objective decisions and taking decisive action, in order to meet BD’s quality and compliance objectives.
- Capable of assuming the technical hands-on leadership of the company's qualities efforts in order to create the credibility necessary to your success.
- Team player, able to bring diverse people and opinions together to provide the optimum solutions for the company, its employees, customers and shareholders.
- ASQ Engineer certification desired.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.
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 health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Primary Work LocationUSA PR - Guaynabo
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