Supplier Quality Engineer: Elevate MedTech Quality On Site

bdx; Canaan (CT); On-site; USD 90,000 - 130,000; Full time

Job summary

BD, a leading medical technology company, seeks a Supplier Quality professional to drive incoming material quality and supplier performance from our CT facility. You will work closely with Production, Engineering, and Material Control to ensure compliance with regulatory and quality requirements.

Responsibilities include supplier audits, disposition of nonconforming materials, and implementing inspection equipment. Strong QA knowledge and auditing experience are essential for success.

Qualifications

• BS or BA in science-related field, QA, engineering, math/stats or equivalent.
• 1 year of supplier quality experience.
• Certified Quality Auditor and ISO 13485 experience are preferred.

Responsibilities

• Perform incoming raw material inspections, approve material releases, and maintain purchasing specifications and process documentation.
• Partner 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 understanding of manufacturing processes to investigate and resolve incoming material quality issues.
• Coordinate disposition of nonconforming materials with Material Control and suppliers.
• Build and maintain supplier relationships while driving improvements in supplier quality performance.
• Conduct supplier audits and support supplier assessments, surveys, and evaluations.
• Participate in selection, validation, qualification, and implementation of inspection equipment, tools, and technologies for quality controls.
• Manage supplier quality activities for BD and external suppliers.
• Lead and support continuous improvement initiatives using QA and operating excellence methodologies.
• Monitor, maintain, and communicate supplier quality performance metrics.
• Collaborate with Engineering to establish process parameters and acceptance criteria for supplier processes.
• Maintain supplier documentation including ASL and Supplier Files.
• Communicate specification changes and coordinate Supplier Change Requests.
• Partner with Canaan-based suppliers to implement and maintain Supplier Quality Agreements.
• Support regulatory, customer, and internal audits (FDA, NSAI, MDSAP, etc.).
• Ensure compliance with safety regulations and BD quality standards.
• Support budget objectives and contribute to performance standard development.

Skills

Supplier quality

Auditing

Regulatory knowledge

Cross-functional collaboration

Education

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

Tools

ISO 13485

IQ/OQ/PQ

DOE's

Job description

BD, a leading medical technology company, seeks a Supplier Quality professional to drive incoming material quality and supplier performance from our CT facility. You will work closely with Production, Engineering, and Material Control to ensure compliance with regulatory and quality requirements.

Responsibilities include supplier audits, disposition of nonconforming materials, and implementing inspection equipment. Strong QA knowledge and auditing experience are essential for success.