BD · 3 hours ago
Supplier Quality Manager
USA CA - Milpitas 155
Full-time
Onsite
Senior Level
$132K/yr - $218K/yr
5+ years expBD is one of the largest global medical technology companies in the world. The Manager of Supplier Quality is responsible for overseeing supplier quality management activities, developing and implementing supplier management programs, and ensuring compliance with relevant regulations.
Health CareMedical DeviceTechnical Support
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
Qualification
Required
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
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
Preferred
ASQ certification desired
Benefits
A valuable, competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
2026-01-22
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-20
Medical Device Network
2026-01-17
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