Senior Supplier Quality Engineer | Paterson, NJ

Detailed Information

  • Location: Franklin Lakes, NJ

  • Company: Becton Dickinson

of our billions of Med Tech 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. 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 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 backssments 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. Support Supplier Quality performance monitoring. Create Supplier Quality Roadmap. 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.

Knowledge and Skills : Auditing experience. Understanding of industry standards and regulations such as ISO 9001, ISO 13485, 21CFR820, ISO 14971, MDSAP, EU MDD/MDR. Excellent written and oral communication skills. Working knowledge of problem-solving techniques such as PDCA, 8D investigation, etc. Ability to handle multiple tasks/projects simultaneously with limited supervision. Ability to work with diverse, multi-national, cross-functional teams. Working knowledge of statistics. Minimum Requirement: BS degree in Engineering, Science, or other related discipline At least 5 years of medical device, biologic, medical, or diagnostic industry experience (or equivalent).

Minimum 3 years in a quality organization dealing with suppliers, customers or Operation-Quality. 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 encourage people with the creativity and aim 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 /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. PDN Primary Work Location USA NJ - Franklin Lakes Additional Locations Work Shift NA (United States of America) Apply Save Job Responsibilities Job Description Summary 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 Med Tech 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. 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 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 backssments 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. Support Supplier Quality performance monitoring. Create Supplier Quality Roadmap. 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.

Knowledge and Skills : Auditing experience. Understanding of industry standards and regulations such as ISO 9001, ISO 13485, 21CFR820, ISO 14971, MDSAP, EU MDD/MDR. Excellent written and oral communication skills. Working knowledge of problem-solving techniques such as PDCA, 8D investigation, etc. Ability to handle multiple tasks/projects simultaneously with limited supervision. Ability to work with diverse, multi-national, cross-functional teams. Working knowledge of statistics. Minimum Requirement: BS degree in Engineering, Science, or other related discipline At least 5 years of medical device, biologic, medical, or diagnostic industry experience (or equivalent).

Minimum 3 years in a quality organization dealing with suppliers, customers or Operation-Quality. 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 encourage people with the creativity and aim 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 /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. PDN Primary Work Location USA NJ - Franklin Lakes Additional Locations Work Shift NA (United States of America) Apply Save Job PDN-9ae7db20-2dba-4c1c-b8ba-a18d92fecad3

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