Supplier Quality Engineer

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.

• →Perform incoming raw material inspections, approve material releases, and maintain purchasing specifications and process documentation.
• →Partner closely with Production, Material Control, Engineering, and cross-functional teams to ensure supplier quality and supplier management requirements are met.
• →Serve as a quality and regulatory resource for plant operations, project teams, and external stakeholders.
• →Develop and maintain a strong understanding of manufacturing processes and products to investigate and resolve incoming material quality issues.
• →Coordinate the disposition of nonconforming materials with Material Control and suppliers.
• →Build and maintain effective supplier relationships while driving improvements in supplier quality performance.
• →Conduct supplier audits and support supplier assessments, surveys, and evaluations.
• →Participate in the selection, validation, qualification, and implementation of inspection equipment, tools, and technologies to ensure accurate and effective quality controls.
• →Manage supplier quality activities for both internal BD suppliers and external suppliers.
• →Lead and support continuous improvement initiatives using established quality and operational excellence methodologies.
• →Monitor, maintain, and communicate supplier quality performance metrics.
• →Collaborate with Engineering to establish process parameters and acceptance criteria that ensure supplier process capability meets product and manufacturing requirements.
• →Maintain accurate supplier documentation, including Approved Supplier Lists (ASL) and Supplier Files.
• →Communicate specification changes to suppliers and coordinate Supplier Change Requests.
• →Partner with Canaan-based internal and external suppliers to implement and maintain Supplier Quality Agreements.
• →Support regulatory, customer, and internal audits, including FDA, NSAI, MDSAP, customer, and corporate audits.
• →Ensure compliance with all company, local, state, and federal safety regulations, policies, and procedures.
• →Uphold BD quality standards through consistent application of Quality Assurance principles, training, communication, and regulatory compliance requirements.
• →Monitor activities within assigned areas to support departmental budget objectives and provide input for budget planning.
• →Understand plant and divisional goals and contribute to achieving them through the development and execution of performance standards.
• →Promote and reinforce safety, environmental, quality, and compliance standards throughout daily operations.

• B.S. or B.A. Degree in Science-related field, Quality Assurance, Engineering, Mathematics/Statistics or equivalent degree.

• 1 year of supplier quality experience.

• Certified Quality Auditor

• Prior auditing experience

• Prior experience with ISO 13485:2016 and or applicable laws

• Prior experience working in the Medical Device field

Knowledge and Skills:

• Working knowledge of Validations, IQ, OQ, PQ, and DOE's is desirable.

• Consistent record of supporting and driving continuous improvement activities in a production environment.

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.