Job Description Summary

Experienced Senior Supplier Quality Engineer experienced in electromechanical subassemblies and knowledgeable in ISO 13485

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:

• 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

• Experience in contracting manufacturer

Education and Experience:

• B.S. or B.A. degree in an engineering or science field.

• Typically requires at least 3 years of experience in Quality / Supplier Quality in a manufacturing environment working in an FDA or ISO regulated environment

• Six Sigma Green Belt and/or Certified (e.g. ASQ) Quality Engineer or equivalent (Prefer Six Sigma Black Belt Certified) desired

Minimum Qualifications:

• 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 Troubleshooting 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

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/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.

Required Skills

Optional Skills

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Primary Work Location

USA CA - Milpitas 155

Additional Locations

USA CA - San Diego (BDB)

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 (https://jobs.bd.com/benefits) .

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

$103,500.00 - $170,800.00 USD Annual

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.