Quality Systems Engineer I
About The Position
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 early‑career 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.
Requirements
- Bachelor’s degree in Engineering, Microbiology, Chemistry, Biomedical Engineering, or a related scientific discipline.
- 0–2 years of experience in a regulated manufacturing or laboratory environment (medical device preferred).
Nice To Haves
- Foundational knowledge of quality systems and problem‑solving 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.
- Hands‑on 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.
Responsibilities
- Support microbiology and sterilization quality activities, including EtO, Gamma, and E‑Beam 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 sampling data.
- 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 follow‑up activities.
- Execute internal process audits to ensure compliance with regulatory and quality system requirements.
- Develop, review, and maintain protocols, reports, and quality documentation related to microbiology and sterilization sciences.
- Partner cross‑functionally 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.
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
501-1,000 employees
