Senior Supplier Quality Systems Specialist

Job Description Summary

Manage the supplier quality program covering raw materials and services obtained from internal and external vendors that are used for production of sub-assembled and finished products. Using established procedures, maintain a comprehensive vendor qualification and certification program to ensure that incoming components/materials comply with the product specifications, BD quality policies, regulatory requirements, and safety regulations. Serve as the primary contact between BD site and suppliers for quality-related inquiries and information.

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.

Responsibilities

• Provide primary oversight and leadership in the selection, qualification, and certification of responsible suppliers to provide materials that meet product specifications.
• Analyze, summarize, and report supplier performance.
• Manage the supplier audit schedule and perform supplier audits. Requires approximately 0 - 5% travel.
• Is a key member of Material Review Board (MRB) and gives input and decisions on tasks.
• Oversees the supplier controls element of the quality management system and ensure site compliance to corporate procedures.
• Support Manufacturing, New Product Development, and Regulatory (as applicable) to ensure supplier systems are in compliance with internal and external guidelines and regulations.
• Own and maintain the list of approved suppliers.
• Provides leadership and oversight in Supplier Governance Board for vendor proposed changes
• Maintain supplier relationships to ensure compliance to supplier controls and product specifications. Initiate supplier corrective actions requests required to maintain the supplier performance at high level.
• Review supplier corrective and preventive actions reports to ensure adequacy and completeness.
• Interface with the buyers, quality engineers, and manufacturing personnel to review nonconformances and customer complaints and identify improvements required for raw materials and components.
• Participate as a member of the corporate supplier management team.May conduct internal audits.
• Provide audit support for customer and regulatory audits (preparation, closure, etc.).
• May participate in corrective and preventive action activities.
• Accumulate and prepare quality information reports on a timely basis.Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
• Participate in product/process driven quality initiates to improve the overall quality of BD products.
• Ensure that all part and supplier qualifications are performed in a timely manner to support business requirements.
• May lead investigations related to material quality problems in partnership with manufacturing, incoming personnel, and suppliers.
• Communicate effectively at all levels within the Quality department, as well as cross-functionally with R&D, Regulatory Affairs, Manufacturing, Supply Chain, Customer Service, Marketing, and other functions as necessary.
• Develop working knowledge of applicable regulatory, corporate and unit requirements.
• Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations.
• Other duties as assigned.

This position requires:

• Bachelor's degree in a scientific discipline with a minimum of 3 years relevant experience or 8 years of a combination of equivalent education and relevant experience.

Preferred qualifications include:

• Leadership and advanced communication skills
• Strong project management skills including scheduling and leading meetings.
• Proficiency in statistical analysis and software.
• Medical device or pharmaceutical experience.
• Supplier quality experience.
• ASQ certified quality engineer (CQE), certified quality auditor (CQA), or auditing experience.
• Experience with analytical problem-solving skills, technical writing skills, automated documentation systems, and root cause analysis.
• 21 CFR 820-21/211 cGMP, ISO 13485 experience.
• Experience with SAP and TrackWise.

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.

Primary Work Location

USA UT - Sandy

Additional Locations

Work Shift

NA (United States of America)