MedTech Supplier Quality Engineer

RXinsider LTD.; Connecticut; On-site; USD 70,000 - 100,000; Full time

Job summary

BD is a global medical technology leader seeking a Supplier Quality professional to ensure material quality from internal and external suppliers in USA CT. You will lead audits, approvals, and quality improvements across supply chains, collaborating with Production, Engineering, and Regulatory teams.

The role requires a BS in a science/engineering field and at least 1 year in supplier quality, with experience in ISO 13485 and IQ/OQ/PQ/DOE.

Qualifications

• 1 year of supplier quality experience.
• Experience with ISO 13485:2016 or medical devices is preferred.
• Strong understanding of validations (IQ/OQ/PQ) and DOE concepts.
• Ability to coordinate supplier audits and manage supplier quality data.

Responsibilities

• Perform incoming raw material inspections, approve material releases, and maintain purchasing specifications.
• Partner with Production, Material Control, Engineering, and cross-functional teams to meet supplier quality requirements.
• Serve as a quality and regulatory resource for plant operations and external stakeholders.
• Develop understanding of manufacturing processes to resolve quality issues.
• Coordinate disposition of nonconforming materials with Material Control and suppliers.
• Build and maintain supplier relationships and drive improvements in supplier quality.
• Conduct supplier audits and support supplier assessments and evaluations.
• Lead and support continuous improvement initiatives using QA methodologies.
• Monitor supplier quality performance metrics and communicate results.
• Collaborate with Engineering to set process parameters and acceptance criteria.
• Maintain Approved Supplier Lists and Supplier Files.
• Communicate changes to suppliers and coordinate Supplier Change Requests.
• Support regulatory audits including FDA, NSAI, MDSAP, etc.
• Ensure compliance with safety regulations and company QA standards.

Skills

Supplier quality

Auditing

Quality systems

Regulatory compliance

Education

Bachelor's degree in Science/Engineering/QA or related field

Job description

BD is a global medical technology leader seeking a Supplier Quality professional to ensure material quality from internal and external suppliers in USA CT. You will lead audits, approvals, and quality improvements across supply chains, collaborating with Production, Engineering, and Regulatory teams.

The role requires a BS in a science/engineering field and at least 1 year in supplier quality, with experience in ISO 13485 and IQ/OQ/PQ/DOE.