Supplier Quality Engineer I

CONMED Corporation; City of Utica (NY); On-site; USD 70,000 - 108,000; Full time

Benefits offered by this job

Competitive compensation

Excellent healthcare coverage

401K with match

Employee Stock Purchase Plan

Tuition assistance

Job summary

CONMED Corporation in Utica, NY is seeking a Supplier Quality Engineer I to ensure external processes, products, and services meet regulatory requirements and quality standards.

The role supports supplier qualification, monitoring, and improvement activities, including audits, PPAP/FAI review, CAPA support, and supplier risk management, across GMP-compliant operations. Collaboration with Purchasing, R&D, Manufacturing, and Regulatory teams is essential.

Qualifications

• 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).

Responsibilities

• Support supplier qualification, audits, and capability assessments.
• Onboard new suppliers with quality agreements and documentation review.
• Maintain Approved Supplier List and supplier records.
• Monitor supplier performance using defect, on-time delivery, and responsiveness metrics.
• Review and approve supplier documentation including: FAI, PPAP, CoC and material certifications.
• Ensure suppliers comply with regulatory requirements (FDA 21 CFR Part 820, ISO 13485, ISO 14971).
• Investigate supplier-related nonconformances and initiate SCARs, verify CAPA effectiveness.
• Participate in supplier audits (on-site, remote, or desk) and support internal and external audits.
• Contribute to supplier risk assessments and risk mitigation strategies.
• Drive continuous improvement in supplier quality and defect reduction.

Skills

FDA regulatory knowledge

Quality systems

Root cause analysis

CAPA & problem solving

Supplier audits

Documentation review

Education

Bachelor's degree in Engineering

Tools

SPC tools

IQ/OQ/PQ validation

Job description

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.

Key Responsibilities

Supplier Qualification & Management

• 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).

Supplier Quality Assurance

• 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).

Incoming Quality & Nonconformance Management

• 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).

Auditing & Compliance

• 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).

Risk Management

• Contribute to supplier risk assessments (criticality, risk ranking).
• Support risk mitigation strategies for high-risk suppliers or materials.

Continuous Improvement

• Drive supplier quality improvement initiatives.
• Analyze trend data and identify opportunities for defect reduction and process improvements.

Cross-Functional Collaboration

• Work closely with Purchasing, R&D, Manufacturing, and Regulatory teams.
• Support product transfers, validations, and design changes involving suppliers.

Qualifications

• 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)

Required Skills & Knowledge

• 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

Preferred Qualifications

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

This position is not open to employer based sponsorship.

Travel 0-20%

Disclosure as required by applicable law, the annual salary range for this position is $69,900 to $108,300. The actual compensation may vary based on geographic location, work experience, education, and skill level. The salary range is CONMED's good faith belief at the time of this posting.

This job posting is anticipated to close on November 7, 2026. We may, however, extend this time period, in which case the posting will remain available on careers.conmed.com.

Benefits:

CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.

• 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

Know someone at CONMED?

CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.

Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5.