Supplier Quality Engineer I

CONMED Corporation • Utica, NY

1d • Onsite

About The Position

The Supplier Quality Engineer I is responsible for ensuring that suppliers and externally provided processes, products, and services meet applicable regulatory requirements and company quality standards. This role supports supplier qualification, monitoring, and improvement activities to ensure compliance with FDA regulations, ISO 13485, and other applicable medical device standards.

Requirements

• Bachelor’s degree in Engineering or related scientific/technical discipline
• 0-3 years of experience in supplier quality, quality engineering, or manufacturing engineering in a regulated industry (medical device preferred)
• Strong working knowledge of: FDA 21 CFR Part 820, ISO 13485 quality systems, Risk management (ISO 14971)
• Expertise in root cause analysis and structured problem-solving methodologies
• Experience with CAPA systems and regulatory compliance expectations
• Hands-on experience with supplier audits and performance management
• Knowledge of validation methodologies (IQ/OQ/PQ) and statistical tools (SPC preferred)
• Ability to interpret engineering drawings, specifications, and technical documentation
• Strong analytical, communication, and decision-making skills

Nice To Haves

• ASQ Certified Quality Engineer (CQE) or equivalent certification
• Lead Auditor certification (ISO 13485)

Responsibilities

• Support supplier selection, evaluation, and qualification activities (e.g., audits, capability assessments).
• Assist in onboarding new suppliers, including quality agreements and documentation review.
• Maintain Approved Supplier List (ASL) and related supplier records.
• Monitor supplier performance using metrics (defects, on-time delivery, responsiveness).
• Review and approve supplier-related documentation including: First Article Inspection (FAI), PPAP (Production Part Approval Process), if applicable, Certificates of Conformance (CoC) and material certifications.
• Ensure suppliers comply with regulatory requirements (FDA 21 CFR Part 820, ISO 13485, ISO 14971 as applicable).
• Support incoming inspection processes and sampling plans.
• Investigate supplier-related nonconformances and defects.
• Initiate and manage Supplier Corrective Action Requests (SCARs).
• Verify effectiveness of corrective and preventive actions (CAPA support).
• Participate in supplier audits (on-site, remote, or desk audits).
• Ensure suppliers adhere to Good Manufacturing Practices (GMP) and internal procedures.
• Support internal and external audits (FDA, notified bodies, customers).
• Contribute to supplier risk assessments (criticality, risk ranking).
• Support risk mitigation strategies for high-risk suppliers or materials.
• Drive supplier quality improvement initiatives.
• Analyze trend data and identify opportunities for defect reduction and process improvements.
• Work closely with Purchasing, R&D, Manufacturing, and Regulatory teams.
• Support product transfers, validations, and design changes involving suppliers.

Benefits

• Competitive compensation
• Excellent healthcare including medical, dental, vision and prescription coverage
• Short & long term disability plus life insurance -- cost paid fully by CONMED
• Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
• Employee Stock Purchase Plan -- allows stock purchases at discounted price
• Tuition assistance for undergraduate and graduate level courses
• Employee Referral Program incentives

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level