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BD (Becton, Dickinson and Company) Senior Supplier Quality Engineer in Franklin Lakes, New Jersey

Job Description Summary

Job Description

The Senior Supplier Quality Engineer is responsible to define and implement the supplier management activities required to approve suppliers and maintain their approved status throughout the product lifecycle. This is achieved by ensuring the conformance of the supplier to applicable quality specifications of components, products, materials, or services delivered to BD, in compliance with BD supplier management policies and procedures, as well as applicable standards and regulations.

Responsibilities Include:

  • Support identification of prospective suppliers

  • Define the optimum supplier approval strategy, and create supplier approval plans

  • Facilitate, manage, and track supplier progress toward Approved status, supporting both new product development launches and sustaining engineering changes

  • Conduct supplier quality audits/assessments as necessary including for-cause audits, and complete follow-up and closure of any non-conformances

  • Author, negotiate, and finalize both Quality and Technical Agreements with suppliers

  • Review and approve supplier FMEAs, SPC strategies, MSA documentation, control plans and inspection methods as required by the Supplier Approval Plan.

  • Provide Supplier Quality Assurance support to all existing suppliers and assigned projects (including suppliers for new product development).

  • Collect and archive all relevant Supplier documentation and required statements

  • Author supplier approval reports

  • Support Supplier Quality performance monitoring

  • Manage changes initiated by suppliers while coordinating with the appropriate project teams

  • Lead problem solving activities with assigned Suppliers related to escalated customer complaints or manufacturing deviations

Education:

  • Bachelor’s Degree in Engineering, Science, or related field

Experience:

  • Minimum of 5 years of experience in Quality in the Medical Device industry, with at least 3 years’ experience in supplier quality

Knowledge, Skills, and Abilities:

  • Lead auditor experience required; certified lead auditor preferred

  • Thorough understanding of industry standards and regulations such as ISO 13485, 21CFR820, ISO 14971, MDSAP, EU MDD/MDR

  • Excellent written and oral communication skills

  • Ability to handle multiple tasks/projects simultaneously with limited supervision

  • Ability to work with diverse, multi-national, cross-functional teams

  • Working knowledge of statistics

  • Proficient in the use of Quality Tools such as, Quality control plans, Failure mode and Effect Analysis (FMEA), and Measurement System Analysis (MSA)

  • Ability to travel 15-20%

“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.”

Primary Work LocationUSA NJ - Franklin Lakes

Additional Locations

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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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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