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Quality Engineer

Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Manufacturing

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. bioMérieux’s global headquarters is located in Marcy L’Étoile, France, and we have more than 11,200 team members in 43 countries. With our distributor network, we serve more than 160 countries. bioMérieux, Inc., our Americas division, has more than 4,000 team members across 12 sites or subsidiaries. bioMérieux, Inc. sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health. Our passionate team members recognize the power of diagnostics and rally behind our mission to help save lives.

 

Position Summary:

The IND Process Investigator is responsible for problem-solving, providing technical knowledge, critical thinking and expertise to lead efforts in support of manufacturactung, product release, compliance and process improvement.  The individual shall also be a subject matter expert that will provide support of current and new products in regard to manufacturing and QC related issues.  This position will also be expected to troubleshoot issues and perform root cause analysis for issues that arise during the manufacturing process at the St. Louis site 


Main Accountabilities:

  • Lead failure investigations and implement solutions (corrective and preventative actions) that solve manufacturing and product problems. Monitior corrective and preventive actions to determin their effectiveness and suitability.
  • Lead the preparation and executon of scientific studies to support root cause determination, prduct impact or process improvement activities.
  • Lead data analysis on product performance characteristics to aid in solving product and process releated issues.
  • Lead the implementation of successful corrective actions that address process-related customer complaints.
  • Prepare protocols using scientific rationale, data analysis and author technical reports.


Studies, Experience, Skills and Qualifications:

  • B.S. 5+ years relevant experience as a process engineer or scientist..  
  • Bachelor degree in a technical field.
  • Good to Extensive knowledge of microbiology, chemistry, math, basic statistics.
  • Significant experience investigating exceptions and other variances, using Quality Engineering Tools and Techniques (i.e. RCA tools such as but not limited to 5-Whys, Fishbone/6M, TapRoot, Kepnor-Tregoe, Comparative Analysis).
  • Demonstrated ability to solve complex technical problems.
  • Demonstrated ability to work in a team environment.
  • Strong PC skills (Word, Excel, Access, etc.).     
  • Strong Organizational skills, decision making, communication, teamwork, and troubleshooting skills.
  • Certification in Six Sigma preferred.
  • Must have experience with statistical tools.
  • Familiarity with a GMP production environment, procedures and  processes.
  • Knowledge and work experience dealing with regulatory agency (e.g., FDA and ISO) requirements preferred.


Additional Information:

  • Lifting (up to 25 lbs) office products and supplies and moving containers of  various materials.
  • Operating within cool temperature and low humidity conditions within the production room.
  • Constant noise is common due to the operation of the air-dry chamber, taping and pouching equipment. 
  • Excellent personal hygiene required. 

 

Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 11,200 bioMérieux team members who already identify with these values!

 

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.


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