BD · 4 hours ago
Staff Supplier Quality Engineer
USA CA - Milpitas 155
Full-time
Onsite
Senior Level, Lead/Staff
$130K/yr - $215K/yr
5+ years expBD is one of the largest global medical technology companies in the world. The Staff Quality Engineer will support the supplier management program at BD Biosciences, focusing on the qualification and approval of suppliers, ensuring compliance with quality and regulatory standards.
Health CareMedical DeviceTechnical Support
Responsibilities
Provide guidance and Quality oversight for key suppliers to ensure suppliers are aligned with BD Quality, Regulatory and Industry standard requirements. Ensure controls meet BD, FDA, and other applicable regulatory requirements and identifying quality needs, product improvements and customer requirements
Drive and Support new product development and sustaining activities in supplier management ensuring supplier compliance and capability for Qualification, Approval, and Sustaining activities. Ensures adequate design control documentation and records are maintained to support life cycle of design history
Provide quality support for Supplier Qualification and Approval steps and are completed adequately including areas in supplier selection, quality planning, risk analysis, critical to quality characteristics, supplier specification and DFM reviews, validations, verifications, quality agreements, supplier history files and other activities as needed
Support activities relating to Field Corrective Actions, when needed
Facilitate and Partner with suppliers to develop strong business and quality relationships ensuring strong communication and collaboration
Establish new initiatives to support ongoing improvement of Supplier Quality Management Systems
Qualification
Required
Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820
Excellent people interaction, team building, leadership, and communication skills including providing effective presentations
Strong background in Manufacturing processes including process development and optimization
Experience in managing variety of commodities including Instrument Finished Goods CMs, PCBAs/ Electronics, Sheet metal, Machined Parts, Optics/Lasers, and Cabling harnesses or Chemistry or Biological products
Proficient in project management, analytical, critical thinking, problem solving and prioritization skills
Demonstrate innovative and implementation skills
Demonstrate knowledge of Statistics and Data Analysis to drive data based results and decisions
ISO 9001/13485 lead auditing experience
Strong solving skills at both process and product level
Experience in SAP, Minitab, and Quality Systems Software (e.g. Trackwise) is a plus
Lead Supplier Capability Assessments
B.S. or B.A. degree in an engineering or science field
Minimum of 5 years of experience in Supplier Quality in a manufacturing environment working in an FDA or ISO regulated environment
Preferred
ASQ certifications desired
Benefits
A valuable, competitive package of compensation and benefits programs
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
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