BD (Becton, Dickinson and Company) Senior Supplier Quality Engineer in Franklin Lakes, New Jersey
Job Description Summary
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.
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
- Bachelor’s Degree in Engineering, Science, or related field
- 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
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.