Position Overview

Senior Chemist, Quality Engineering

Support the development and manufacture of medical devices. Work with Manufacturing, R&D, and/or R&D Chemist to resolve product quality issues. Support manufacturing process changes, product design changes/improvements, and the implementation of new products. Job duties:
  • Work with Manufacturing, R&D/ Engineers, and/or R&D Chemists to support design transfer (manufacturing process - MP, inspection - QS, test method- TM validation) by reviewing test protocols and reports.
  • Work with R&D Chemists to support analytical test method validation by reviewing test protocols and reports.
  • Work with supplier to maintain high-quality levels of incoming purchased materials.
  • Work with R&D Engineers to support implementation of new products by reviewing quality and testing plans.
  • Work with cross-functional team to create risk documents (i.e., FMEA, Risk Analysis, Design, and Process FMEA).

    • Bachelor’s degree in Chemistry, Chemical Sciences, or a related field.
    • Minimum of seven (7) years of related experience.
    • Strong written and verbal communication skills.
    • Must be able to perform and interpret GC and HPLV testing..
    Desired Qualifications
    • Knowledge of medical product manufacturing.
    • Knowledge of medical device risk analysis.
    • Knowledge of medical product quality assurance (including the requirements test protocols, test reports and statistical techniques).
    • Knowledge of medical product design control process.
    • Knowledge of 21CFR820, ISO9001/13485, EN ISO14971, IEC 62366.