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Engineer (Quality Engineer Investigator)

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:

This position is to investigate and manage day to day Non Conforming Material-NCMR’s. When raw materials and/or product does not meet specification, the role of the investigator is to follow procedures that will help guide them in the development of writing  an investigation to determine root cause and possible corrective actions to the problem.

 

Responsibilities:

  • Investigate and manage day to day Non Conforming Material-NCMR’s  related to raw materials and/or finish good in the manufacturing process. (This will encompass the majority of your time)
  • Evaluate, develop, and improve manufacturing processes by studying product and manufacturing methods.
  • Collaborate with Supply Chain, Reagents Operations Engineering, Incoming QC, Final QC, Manufacturing, Quality, and Purchasing to identify and lead material and/or finish good  related issues to ensure optimum manufacturing process in terms of keeping manufacturing moving.
  • Manage materials related to quality issues in the area of Tape, Webbing, Tubing, and Card production. 
  • Provide daily decisions on service, manufacturing, and engineering to ensure product quality.
  • Participate in the development of long-term strategies for materials and process improvements.
  • Conduct validations and feasibility studies to assess new technologies or process improvements in material or process design.
  • Support CAPA’s with regard to  root cause analysis and fishbone activities related to material and/or manufacturing processes.
  • Ensure all activities comply with Good Manufacturing Practice (GMP), ISO, and Quality System requirements.
  • Ensure that all health, safety, and environmental requirements are fulfilled.
  • Support the development of capital business cases for new material/process/equipment development projects.
  • Help Resolve quality related issues on the manufacturing floor and/or incoming QC.
  • Obtain and analyze data, as required, to ensure key metrics, such as, but not limited to OEE, MSP, and yield are achieved.

 

Studies and Experience:

  • Bachlors Degree required in Scientific/Engineering Area: Such as Biology, Chemistry, Manufacturing/Mechanical Engineering is required.
  • 3+ years of Non-Conforming investigation writing is preferred.
  • 3+ years of experience working  in an FDA Regulated Environment is preferred.

 

Skills and Qualifications:

  • Background working in a high volume manufacturing setting.
  • 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.

 

Physical Requirements:

  • Extensive standing, repetitive hand and arm motions, ability to climb steps.
  • Lifting (up to 50Lbs) and moving containers of cartons, tubes, and printed materials.
  • Must be able to push a wheeled cage that can weigh up to 600 lbs fully loaded.
  • 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. 
  • Appropriate gowning requirements necessary for the production areas.  Gloves are required to handle the product. Hairnet, clean room gowns and/or lab coats are required. Safety glasses and hearing protection are required personal protective gear. 

 

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

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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