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About the Role
The Supplier Quality Engineer I ensures suppliers meet regulatory requirements and company quality standards, supporting qualification, monitoring, and improvement activities for medical device compliance.
Responsibilities
- Support supplier selection, evaluation, and qualification activities.
- 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.
- Review and approve supplier-related documentation.
- Ensure suppliers comply with regulatory requirements.
- 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.
- Participate in supplier audits.
- Ensure suppliers adhere to Good Manufacturing Practices (GMP) and internal procedures.
- Support internal and external audits.
- Contribute to supplier risk assessments.
- 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 improvements.
- Work closely with Purchasing, R&D, Manufacturing, and Regulatory teams.
- Support product transfers, validations, and design changes involving suppliers.
Requirements
- 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)
- Strong working knowledge of FDA 21 CFR Part 820, ISO 13485 quality systems, and 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
- ASQ Certified Quality Engineer (CQE) or equivalent certification (Preferred)
- Lead Auditor certification (ISO 13485) (Preferred)
- This position is not open to employer based sponsorship.
Skills
- FDA 21 CFR Part 820
- ISO 13485
- ISO 14971
- Root cause analysis
- Structured problem-solving
- CAPA systems
- Regulatory compliance
- Supplier audits
- Performance management
- Validation methodologies (IQ/OQ/PQ)
- Statistical tools (SPC)
- Engineering drawing interpretation
- Specification interpretation
- Technical documentation interpretation
- Analytical skills
- Communication skills
- Decision-making skills
Work Type
- Travel 0-20%
Experience Level
- 0-3 years of experience
Education Level
- Bachelor’s degree in Engineering or related scientific/technical discipline
Salary/Compensations
- $69,900 to $108,300
Benefits
- 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
- Employee Referral Program incentives
About the Company
- 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.
Equal Opportunity
- 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.