Supplier Quality Engineer I

CONMED; City of Utica (NY); Presencial; USD 70.000 - 108.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Healthcare benefits

Disability & life insurance

401K match

Employee Stock Purchase Plan

Tuition assistance

Referral program

Descripción de la vacante

CONMED is seeking a Supplier Quality Engineer I to ensure supplier processes meet FDA, ISO 13485, and medical device standards. You will support supplier qualification, on-boarding, and ongoing performance with audits and documentation reviews.

The role requires 0–3 years in supplier quality or manufacturing engineering in regulated environments, strong problem-solving, and cross-functional collaboration with Purchasing, R&D, Manufacturing, and Regulatory teams. Travel 0–20% is possible.

Formación

• Bachelor’s degree in Engineering or related technical discipline.
• ASQ CQE certification or equivalent preferred.
• Lead Auditor certification (ISO 13485) preferred.
• 0–3 years of supplier quality/quality engineering experience in a regulated industry (medical device preferred).

Responsabilidades

• Support supplier qualification, audits, and capability assessments.
• Review and approve supplier documentation (FAI, PPAP, CoC, material certs).
• Investigate supplier nonconformances and manage SCARs.
• Support CAPA and verify effectiveness of corrective actions.
• Participate in supplier audits (on-site/remote/desk) and ensure GMP compliance.
• Assist in product transfers, validations, and design changes involving suppliers.

Conocimientos

FDA 21 CFR 820

ISO 13485

ISO 14971

Regulatory compliance

Root cause analysis

CAPA

Supplier audits

Validation IQ/OQ/PQ

SPC

Engineering drawings interpretation

Analytical skills

Communication skills

Decision making

Educación

Bachelor’s degree in Engineering or related technical discipline

ASQ CQE certification

Lead Auditor certification (ISO 13485)

Descripción del empleo

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 & KnowledgeStrong 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 methodologiesExperience with CAPA systems and regulatory compliance expectationsHands-on experience with supplier audits and performance managementKnowledge of validation methodologies (IQ/OQ/PQ) and statistical tools (SPC preferred)Ability to interpret engineering drawings, specifications, and technical documentationStrong analytical, communication, and decision-making skillsPreferred QualificationsASQ Certified Quality Engineer (CQE) or equivalent certificationLead 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. Please submit your application as soon as possible as we will be reviewing applications on a rolling basis as we receive them.Benefits:CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.Competitive compensationExcellent healthcare including medical, dental, vision and prescription coverageShort & long term disability plus life insurance - cost paid fully by CONMEDRetirement Savings Plan (401K) - CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay periodEmployee Stock Purchase Plan - allows stock purchases at discounted priceTuition assistance for undergraduate and graduate level coursesKnow someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!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.