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Quality Systems Engineer I

2 months ago

Utica, New York, United States CONMED Corporation Full time
Job Title: Quality Systems Engineer I

CONMED Corporation is seeking a highly skilled Quality Systems Engineer I to join our team. As a Quality Systems Engineer I, you will play a critical role in ensuring the quality of our processes and finished devices.

Key Responsibilities:
  • Provide quality system support and leadership to ensure the quality of processes and finished devices.
  • Develop and implement procedures to assure the quality of both internally produced product and purchased material.
  • Support Quality Engineering, Manufacturing Engineering, Manufacturing Operations, Safety, Regulatory and Compliance departments regarding Microbiology and Sterilization Sciences and requirements.
  • Coordinate EtO, GAMMA, E-Beam dose settings/audits/annual assessments and validations, including protocols and final reports.
  • Oversee environmental monitoring of the controlled areas, to include trending analysis.
  • Maintain product bioburden and environmental sampling to include trending and analysis.
  • Assist in the identification, investigation, and implementation of corrective and preventive actions (CAPA).
  • Assist cross functional teams in the root cause analysis.
  • Investigate and resolve process and product issues to reduce or eliminate quality problems on products, processes, and materials used throughout product lifecycles.
  • Remain knowledgeable and current with applicable regulations, standards, and guidance documents.
Requirements:
  • BS in Engineering or related discipline (microbiology, chemistry, biomedical engineering).
  • Industry experience having an applied knowledge of ISO13485, FDA 21CFR820, and/or other regulations and standards.
  • Working knowledge of QSR/ISO requirements. 21CFR820, ISO13485, ISO14644, ISO11135, ISO11137.
  • Working knowledge of quality assurance principles and practices. Quality certification (CQE, CQA or Lead Assessor) desirable.
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.