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Quality Engineer (R&D Microbiology)

Company: Biom--rieux
Location: Saint Louis
Posted on: September 15, 2018

Job Description:

A strong Scientific and technological pioneering spirit drives bioM--rieux development since its creation in 1963. We design innovative in vitro diagnostic solutions for our customers that initiate new forms of scientific partnerships to be at the forefront of the most advanced technologies. Our presence in more than 150 countries with 9,400 employees worldwide secures bioM--rieux commitment to public health. bioM--rieux products are used to diagnose infectious diseases, they provide high medical value results for cancer screening and monitoring, cardiovascular emergencies and contamination to improve patient health and ensure consumer safety. Products also include industrial microbiological controls to detect microorganisms in food, pharmaceutical and cosmetic products. We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities. A strong Scientific and technological pioneering spirit drives bioM--rieux development since its creation in 1963. We design innovative in vitro diagnostic solutions for our customers that initiate new forms of scientific partnerships to be at the forefront of the most advanced technologies. Our presence in more than 150 countries with 9,400 employees worldwide secures bioM--rieux commitment to public health. bioM--rieux products are used to diagnose infectious diseases, they provide high medical value results for cancer screening and monitoring, cardiovascular emergencies and contamination to improve patient health and ensure consumer safety. Products also include industrial microbiological controls to detect microorganisms in food, pharmaceutical and cosmetic products. We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities. Quality Specialist: R&D Quality Microbiology

  • Executes assigned quality projects, with guidance from technical quality expert (depending on his (her) level of experience), using engineering principles, business standards, practices, procedures, and project requirements.
  • Assures proper documentation of technical data generated for the assigned projects and/or tasks consistent with applicable quality directives and procedures.
  • Documents quality systems and programs to ensure compliance with local / global regulatory requirements and corporate quality systems requirements.
  • Participates in the following activities contributing to QMS compliance: CAPA (including analysis of data and trends in complaints, nonconforming materials and root cause analysis), change control and continuous improvement, supplier quality, internal audits, quality training, etc.
  • Participates and communicates status, business issues, and significant developments in projects.
  • Serve as contact for assigned projects and provide coaching/mentoring for project managers and/or project team in regards to the Product Development Process (PDP) and Design Control.
  • Certified Quality Engineering (CQE) desired.
  • Medical Technology experience in microbiology environment or antimicrobial susceptibility testing experience highly desired. Qualifications required:
    • Bachelor Degree with 3-5 years' work experience or equivalent experience in industry or strong interfaces with R&D, including QMS experience.
    • Competence in the selection and use of Quality Engineering Tools and Techniques.
    • Ability to work independently and in team environment.
    • Ability to effectively communicate written and verbally.
    • Good knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO 13485, ISO 14971, 21CFR 820 QSR, CSA, VDE, etc.). bioM--rieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity. To apply:

      Keywords: Biom--rieux, St. Louis , Quality Engineer (R&D Microbiology), Engineering , Saint Louis, Missouri

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