New

Quality Systems Engineer I

CONMED Corporation
life insurance, long term disability, tuition assistance, 401(k)
United States, New York, Utica
525 French Road (Show on map)
Apr 15, 2026
CONMED is seeking a Quality Engineer I to support microbiology and sterilization-related quality systems for medical device manufacturing. This role provides hands-on quality engineering support across environmental monitoring, bioburden, sterilization validations, and compliance activities, while partnering closely with Manufacturing, Quality Assurance, Regulatory, and Operations teams. The position is ideal for an earlycareer quality professional with a foundation in microbiology or life sciences who is looking to grow in a regulated medical device environment. This position is fully onsite at our Utica, NY location. Key Responsibilities Support microbiology and sterilization quality activities, including EtO, Gamma, and EBeam dose setting, audits, annual assessments, and validations. Coordinate and maintain environmental monitoring programs, including data trending, analysis, and continuous improvement actions. Maintain and trend product bioburden and environmental samplingdata. Assist in the identification, investigation, and implementation of CAPAs, including root cause analysis and effectiveness checks. Support internal, customer, and regulatory audits, including preparation, execution, and followup activities. Execute internal process auditsto ensure compliance with regulatory and quality system requirements. Develop, review, and maintain protocols, reports, and quality documentationrelated to microbiology and sterilization sciences. Partner crossfunctionally to investigate and resolve process and product quality issues. Support training activities related to microbiology, sterilization, and quality system processes. Maintain current knowledge of applicable regulations, standards, and guidance documents. Required Qualifications Bachelor's degreein Engineering, Microbiology, Chemistry, Biomedical Engineering, or a related scientific discipline. 0-2 years of experiencein a regulated manufacturing or laboratory environment (medical device preferred). Preferred Qualifications Foundational knowledge of quality systems and problemsolving methodologies. Ability to analyze data, identify trends, and support corrective actions. Strong written and verbal communication skills. Experience working in a medical device or regulated industry. Working knowledge of FDA QSR (21 CFR 820)and ISO 13485. Familiarity with ISO 11135, ISO 11137, ISO 14644, or related microbiology/sterilization standards. Handson experience with aseptic technique, laboratory sample collection, or environmental monitoring. Exposure to quality tools such as CAPA, audits, validations, and root cause analysis. Quality certifications (CQE, CQA, Lead Auditor) a plus, but not required. Why Join CONMED Work in a highimpact quality rolesupporting lifesaving medical devices. Gain exposure to sterilization sciences and microbiologywithin a global medical device organization. Opportunity for career growthwithin Quality Engineering and Quality Systems. Collaborative culture focused on continuous improvement, compliance, and patient safety. Travel Expectations 0-20% This positionis not eligible for employer-visa sponsorship. Disclosure as required by applicable law, the annual salary range for this position is $67,496 - $97,240. 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. 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! 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.