Supplier Quality Engineer I — Regulated Medical Device Quality

CONMED Corporation; City of Utica (NY); Presencial; USD 70.000 - 108.000; Tempo integral

Benefícios oferecidos por esta vaga

Competitive compensation

Excellent healthcare coverage

401K with match

Employee Stock Purchase Plan

Tuition assistance

Resumo da vaga

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.

Qualificações

• 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).

Responsabilidades

• 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.

Conhecimentos

FDA regulatory knowledge

Quality systems

Root cause analysis

CAPA & problem solving

Supplier audits

Documentation review

Formação

Bachelor's degree in Engineering

Ferramentas

SPC tools

IQ/OQ/PQ validation

Descrição da vaga

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.