Job Description Summary
Job Description
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.
As the Sr. Manager, Quality, you will lead the BOC Supplier Quality Management organization with direct oversight and support for the BOC Supplier Management program. You will also lead, with the direction of the BOC QA VP, the Quality Assurance and Regulatory Compliance of the BOC Guaynabo facility. You will be responsible for generating, updating, and implementing BOC procedures on supplier selection, supplier management, audits of suppliers, and will support the management of critical supplier-related issues in terms of overall Mexican plants supplier quality management process. You will report directly to the BOC VP of QA.
Responsibilities
Strategy and Execution
Develop and implement a comprehensive BOC supplier management program in coordination with the BOC Quality Assurance VP, BD Global Supplier Director, Division and Plant QA heads.
Represent BOC on the BD SQM council and partner with them to implement, maintain and improve BD supplier quality management program.
Define, prepare, document, and ensure the implementation of BOC procedures regarding supplier management to include the following critical aspects of the process lifecycle: supplier planning, selection, evaluation, control, audits monitoring and feedback. These procedures will serve as a framework for regulatory compliance and business optimization in accordance with the established supplier quality management strategy.
Works with the Strategic Sourcing department to identify new suppliers, maintain current suppliers, and/or meet corporate or marketing division objectives for suppliers.
Develops, implements, monitors, and directs performance for the annual supplier management quality goals.
Establishes effective supplier management quality procedures for BOC and the Mexico sites to ensure compliance with the BD Corporation, FDA, and global quality system requirements, and to ensure operational goals are met.
Supervisory/Management Responsibilities
May perform supplier audits (acquisition suppliers, strategic sourcing suppliers, and others as deemed necessary by management) to ensure robust quality systems at suppliers or "for cause" audits during quality investigations.
Ability to handle a variety of individual projects, while directing the efforts of the supplier management activities at the Mexico facilities at the same time.
Reviews and approves the supplier audit schedules for the three Mexico plants.
Cross-functionally, and in coordination with the associated marketing divisions, oversees the implementation of supplier corrective action plans.
Provides leadership and guidance to the BOC MX sites for complex supplier compliance issues with expected impact on BD as a whole. This function includes monitoring watch lists and regulatory notices of field action for suppliers of the three manufacturing sites.
Maintains appropriate involvement in medical device industry and quality assurance associations to ensure the company remains current on industry trends and regulations.
Works effectively with a variety of people including suppliers, corporate officers and staff, medical and technical professionals, BD marketing divisions, and potentially regulatory agencies.
The incumbent must be able to function as both an individual contributor and overall manager of activities in a matrix organization. Also, will work closely with plant, marketing division, and corporate staff, across multiple functions including regulatory, quality, R&D, operations, and supply chain personnel.
Fiscal Responsibilities
Supports cost improvement projects (CIPs) through suppliers without compromising quality, integrity, design, or business needs.
Provides leadership and guidance to the BOC MX sites to perform the due diligence necessary to adequately assess supplier performance before acquisitions become final and to prepare plans to bring those suppliers into the three Mexico plants, including any improvement plans that may be necessary.
Requirements
Experience & Education
B.S. degree in Engineering or the Physical or Biological Sciences.
10 years' quality, compliance, and regulatory experience in the medical device industry. Combination product, Regulatory requirements and/or pharmaceutical experience preferred.
5+ years managing supplier quality management program in the medical device or drug industry preferably in a corporate function.
5+ year's personnel management experience.
Extensive experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices, pharmaceuticals, and combination products.
Certified Quality Professional (e.g. ASQ CQM/OE, CQE, CQA) - only one of the listed will satisfy the requirement.
Fully Bilingual (as applicable to local language and English).
Knowledge, Skills, and Abilities
Expertise in US and international regulations (EN, ISO, MDD, cGMP/QSR) governing the medical device industry and skills and expertise to keep the plant on state of compliance.
Demonstrated ability to direct and provide advice on the use of process excellence and system design methodologies and tools to investigate and determine root cause, assess compliance risk, and establish comprehensive and effective actions plans.
Effective project management, communication and organizational skills are essential.
Demonstrated ability to effectively collaborate and partner with all levels of management at local office, plants and division level sites while maintaining an appropriate assertive style.
Excellent oral and written communication skills.
Knowledge of fundamental quality engineering principles such as Process Validation and understanding of basic applied statistics, statistical sampling plans, process control & capability and advanced statistical methodologist such as DOE.
Broad understanding of manufacturing processes.
Ability to work in matrix management and able to work collaboratively and cross-functionally as well as across business units.
Ability to conduct training and present material to a wide range of audiences.
Ability to serve in leadership roles on projects or assignments.
Ability to identify opportunities for quality, service, and cost improvements.
Ability to participate and provide leadership on teams and maintain positive work environment with those teams.
While performing the duties of this job, the employee is regularly required to stand, walk, sit, and use hands to manipulate, handle, or feel objects, tools, controls, and office equipment. The employee is occasionally required to reach with hands and arms, and stoop, kneel, or crouch.
Travel by air and on the road throughout the world is required. Incumbent must be physically able to travel domestically and internationally.
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.
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.
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.
PDN
Primary Work Location
USA PR - Guaynabo
Additional Locations
Work Shift
