Supplier Quality Engineer
Listed on 2026-07-26
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers
Job Title
Job Description
Responsibilities:
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.
Required Qualifications:
B.S. or B.A. Degree in Science-related field, Quality Assurance, Engineering, Mathematics/Statistics or equivalent degree.
1 year of supplier quality experience.
Preferred Qualifications:
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.
Primary Work Location
USA CT - Canaan
Additional Locations
Work Shift
US BD 1st Shift 8am-430pm (United States of America)
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