Supplier Quality Manager

Becton Dickinson Medical Devices • Milpitas, CA

22h • Onsite

About The Position

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. 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.

Requirements

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

Nice To Haves

• ASQ certification desired.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level