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. 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 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? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!
