Supplier Quality Engineer I

CONMED Corporation • Utica, NY

5d • $69,900 - $108,300

About The Position

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

The position supports supplier selection, evaluation, qualification, onboarding, documentation review, and maintenance of supplier records. It reviews supplier quality documentation, monitors supplier performance, supports incoming inspection, and investigates supplier-related nonconformances. The role also participates in audits, risk assessments, corrective and preventive action activities, and supplier quality improvement initiatives.

Working cross-functionally with Purchasing, R&D, Manufacturing, and Regulatory teams, the Supplier Quality Engineer supports product transfers, validations, and supplier-related design changes. Travel is 0–20%. The position is not open to employer-based sponsorship.

The disclosed annual salary range is $69,900 to $108,300. Actual compensation may vary based on geographic location, work experience, education, and skill level. The posting is anticipated to close November 7, 2026, though the period may be extended.

Requirements

• Bachelor’s degree in Engineering or a related scientific or technical discipline.
• 0–3 years of experience in supplier quality, quality engineering, or manufacturing engineering in a regulated industry; medical device experience is preferred.
• Strong working knowledge of FDA 21 CFR Part 820, ISO 13485 quality systems, and ISO 14971 risk management.
• 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 such as IQ/OQ/PQ and statistical tools; SPC is 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).
• Medical device industry experience.
• Knowledge of statistical tools, particularly SPC.

Responsibilities

• Support supplier selection, evaluation, and qualification activities, including audits and capability assessments.
• Assist with onboarding new suppliers, including quality agreements and documentation review.
• Maintain the Approved Supplier List (ASL) and related supplier records.
• Monitor supplier performance using metrics such as defects, on-time delivery, and responsiveness.
• Review and approve supplier-related documentation, including First Article Inspection (FAI), PPAP where applicable, Certificates of Conformance (CoC), and material certifications.
• Ensure suppliers comply with applicable regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Support incoming inspection processes and sampling plans.
• Investigate supplier-related nonconformances and defects.
• Initiate and manage Supplier Corrective Action Requests (SCARs), and verify corrective and preventive action effectiveness with CAPA support.
• Participate in supplier audits, including on-site, remote, and desk audits.
• Ensure suppliers adhere to Good Manufacturing Practices (GMP) and internal procedures.
• Support internal and external audits involving FDA, notified bodies, and customers.
• Contribute to supplier risk assessments, including criticality and risk ranking, and 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 improvement.
• Work with Purchasing, R&D, Manufacturing, and Regulatory teams.
• Support product transfers, validations, and design changes involving suppliers.

Benefits

• Medical, dental, vision, and prescription coverage.
• Short- and long-term disability insurance and life insurance, with costs paid fully by CONMED.
• Retirement Savings Plan (401(k)) with dollar-for-dollar matching and the potential for up to 7% per pay period.
• Employee Stock Purchase Plan offering discounted stock purchases.
• Tuition assistance for undergraduate and graduate-level courses.
• Employee Referral Program incentives.
• Competitive compensation.

What This Job Offers

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