Job Description Summary

The Manager of Supplier Quality reports to the Plant Quality Head, BD Biosciences (BDB) Business Milpitas Unit. This position is responsible for all aspects of the BDB supplier quality management including quality management of the OEM instruments and consumable materials. This role will oversee supplier management activities at all BDB Milpitas and other sites as needed and will be responsible for development and implementation of the BDB-Wide supplier management program. The role will have direct reports in Milpitas, CA and will establish indirect oversight over other BDB facilities as needed. An individual in this position will have the responsibility of development and execution of the supplier management quality strategy and plan, development and execution of the supplier evaluation, assessment and audit schedules, ensuring training and availability of supplier auditors for BDB. The supplier management organization will also be responsible for complaint investigation and trending activities for OEM instruments and consumables. This position is responsible for planning and implementing a Supplier Quality strategy for BDB that is aligned with key strategic business strategies. The position implements policies to ensure compliance with applicable US federal regulations, California state requirements, and global regulations.

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. 

Key Responsibilities for this Role: 

• Develop and execute quality strategy for supplier management activities and establish goals and metrics for Category suppliers.
• Manage and ensure timely and effective customer complaint closure for OEM instruments and consumables.
• Establish strong links with OEM and key supplier organizations and build a culture of continuous improvement with key BDB suppliers.
• Lead, develop, engage and mentor quality organization responsible for supplier management under direct supervision and across BDB manufacturing plants.
• Continuously improve quality processes and quality system with the goal of improving regulatory compliance, product quality, cost and customer satisfaction.
• Establish quality agreements with key BDB suppliers.
• Proactively manage quality of the OEM, component and subassembly suppliers.
• Lead implementation and utilization of quality tools such as six sigma, risk management, SPC, root cause analysis, and DOE for supplier management organization.
• Maintain quality management responsibilities in appropriate databases and serve as the BDB representative on the corporate supplier management network.

Key Qualifications and Attributes:

• Supplier Quality Manager should possess strong knowledge of WW medical device regulations and quality sciences with specific focus on Class II and CE-IVD(R) manufacturing and purchasing controls.  An In-Vitro-Diagnostic Knowledge is required.
• An individual in this role must have excellent leadership, communication, organization and project management skills.
• Strong knowledge of supplier management practices is required.
• The ability to make timely critical decisions regarding product quality and/or quality system compliance.
• The ability to effectively lead teams and influence.
• An expert understanding of quality engineering sciences and their application to supplier controls.
• A thorough understanding of 21 CFR §820, ISO 13485, ISO 9001 and ISO 14971.
• Experience as an interface in regulatory compliance audits such as the FDA, ISO, PAL, Anvisa, MDSAP and others.
• The ability to prepare, and understand technical documentation such as Engineering Drawings, Operating Procedures, Work Instructions, Technical/Validation Studies, etc.
• The ability to assess and articulate risk when evaluating a situation.
• The ability to perform thorough investigations, identify root cause(s) of an issue, and propose appropriate corrective action(s).
• The ability to communicate effectively in writing and orally, to organize work, and to achieve results when working alone or in teams.

Position Requirements

EDUCATION

• Bachelor of Science in Engineering, Science, or other technical discipline is required. 

LICENSES OR CERTIFICATIONS

• ASQ certification desired.

EXPERIENCE

• A minimum of 5 years of quality assurance or relevant experience.  A minimum of 2 years of quality leadership or relevant experience.  Experience should be in the Medical Device or Bioscience industry.
• Significant experience in FDA regulations and ISO requirements. Ideally previously involved with remediation activities within manufacturing, design, and transactional organizations.

SPECIAL SKILLS

• Good communication and presentation skills, Project Management, Trackwise systems, SAP.
• Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.

KNOWLEDGE OF SPECIFIC PROCEDURES/PRACTICES

• Knowledge of US and International regulations and standards that apply to the in vitro diagnostic and medical device industry, including FDA Quality Systems Regulations, MDSAP, ISO 13485 & 9001, ISO 14971, EU MDD/IVD, EU MDR/IVDR, SOR/98-282, TG(MD)R, RDC 16, Ordinance #169.
• In-depth understanding of the application of QS to the medical device industry.

COMPLEXITY OF DUTIES

• Must be able to balance a complex agenda, ability to multitask.
• Must be well organized and methodical. Partners with R&D, Operations, NPD Quality Engineering, Quality Leaders of all manufacturing sites.
• Works across BDX to share improvements and learn from others on areas for potential improvements.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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 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

.

Primary Work Location

USA CA - Milpitas 155

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$132,400.00 - $218,400.00 USD Annual