Supplier Quality Engineer

Job Description Summary

The Supplier Quality Engineer manages the supplier quality program ensuring that suppliers deliver quality parts, materials, and services. The SQE implements and maintains a comprehensive supplier management system to ensure that incoming materials comply with specifications. The SQE collaborates with suppliers to resolve quality issues and validate/verify supplier changes.

• Is responsible for incoming raw material inspections, raw material release and maintenance of buy specifications and process documentation.
• Works closely with Production, Material Control, and other departments to ensure all supplier quality and supplier management activities are being met.
• Acts as a resource to work groups and project teams, within the plant and outside the plant relative to quality and regulatory issues.
• Maintains familiarity with manufacturing processes and products to evaluate the cause and effect of incoming material defects.
• Coordinates the disposition of rejected materials with material control and suppliers.
• Maintains supplier relationships and initiates actions to provide required supplier quality performance.
• Conducts supplier audits and coordinates other assessments/surveys.
• May be engaged in evaluating, selecting, validating, and qualifying equipment, tools, technologies, etc. to assure accurate inspection.
• Provides management of suppliers internal to BD as well as external suppliers.
• Supports and/or leads projects using continuous improvement tools and methodologies.
• Maintains and communicates supplier quality metrics.
• Works with engineering teams to define process parameters and criteria to ensure supplier process capability is effective to meet product and process requirements.
• Maintains accuracy and completeness of all Supplier Files and the Approved Supplier List (ASL).
• Communicates specification changes to suppliers and coordinates Supplier Change Requests.
• Works with Canaan suppliers (Internal and External) to implement Supplier Quality Agreements.

• Supports a variety of audits including FDA, NSAI, MDSAP, customer audits and corporate internal audits.
• Aligns with, and is responsible for enforcing, all local, state, federal and BD safety laws, policies/procedures.
• Aligns with all local BD quality policies/practices through consistent application of sound Quality Assurance principles. Ensures compliance through appropriate communication, training, and education of sound Quality Assurance principles. Responsible for the activities and programs as defined for this position in the Quality Systems Manual – BD Canaan.
• Performs other job‑related duties as assigned.
• Observes and reinforces all safety, environmental and quality system standards.
• Controls activities within their scope of control, such that departmental budgets are met, and contributes information as required to establish departmental budgets.
• Is familiar with plant and divisional goals and develops standards of performance that will contribute to the accomplishments of those goals.

• B.S. or B.A. Degree in a science‑related field, Quality Assurance, Engineering, Mathematics/Statistics or equivalent degree.
• Certified Quality Auditor – highly desirable.

• Prior auditing experience – preferred.
• Working knowledge of Validations, IQ, OQ, PQ, and DOE’s – desirable.
• Consistent record of supporting and driving continuous improvement activities in a production environment.
• Prior experience with ISO 13485:2016 and/or applicable laws – preferred.
• Minimum one year of supplier quality experience.

Level 2 – Light Work:
Exerts up to 20 pounds occasionally, and/or 10 pounds of force frequently, or negligible constantly. Requires walking or standing to a significant degree or sitting constantly and pushing/pulling controls.

Strong verbal, written, analytical, persuasive, and interpersonal skills. Working knowledge of computers. Organizational skills required. Ability to accept responsibility and perform duties with little or no direct supervision. Strong understanding in the use/application of statistics.

Ability to operate a personal computer,…