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Manager, Quality Engineering

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

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

 

 

Position Summary:

Provide support for Reagent Raw Material related projects within the Reagent Operations Engineering Department. This includes leading and documenting  projects from start to finish.


Main Accountabilities:

  1. Main accountabilities are to lead and manage raw material projects. 
  2. Develop and execute change controls and other compliance related documentation for raw materials including qualification protocols.
  3. Collaborate with  Reagents Operations Engineering, Manufacturing, Purchasing, and Quality to lead projects and ensure the optimum manufacturing process in terms of keeping manufacturing moving.
  4. Organize and lead meetings as required to support project timelines.
  5. Participate in the development of long-term strategies for material and process improvements.
  6. Conduct feasibility studies on raw materials.
  7. Support root cause analysis and fishbone activities related to non-conforming materials.
  8. Provide timely and accurate reporting on projects.
  9. Ensure all activities comply with Good Manufacturing Practice (GMP), ISO, and Quality System requirements.
  10. Ensure that all health, safety, and environmental requirements are fulfilled.
  11. Support any project or task that requires keeping manufacturing  running, and ensure quality product is being shipped to customers.

 

Other Accountabilities:

 

  1. Support any project or task that requires manufacturing to keep moving, supplied with raw materials,  and ensure quality product is being shipped to customers. This can include performing NC investigation writing and disposition. 

 

Studies, Experience, Skills and Qualifications:

  • Bachelor's Degree in Process, Manufacturing, Materials, Mechanical or Industrial Engineering required
  • 3+ years project management experience is required.
  • 3+ years of experience working in a Medical Device is prefered. 
  • Ability to collaborate professionally with all levels of management in a cross-functional team environment is required.
  • Knowledge of FDA/ISO regulations and process validation is preferred.
  • Strong Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
  • Must have strong communication and interpersonal skills.
  • Must have strong analytical and problem-solving skills.

 

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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