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Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Engineering
A family-owned company, bioMerieux 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.
Description
- Perform all work in compliance with company quality procedures and standards.
- Directs cross-functional teams through 8Ds, CAPAs, and failure investigations, root cause analysis, and corrective/preventive action responses.
- Responsible for developing and monitoring Key Performance Indicators of product reliability and manufacturing process reliability and initiating action plans when trends are out of control.
- Partners with data science, manufacturing, and R&D technical teams to develop new queries, reporting, and analysis for failure investigations.
- Responsible for reporting in Post Market Surveillance Reviews and Quality Management Reviews.
- Responsible for reporting and investigating production and finance data regarding scrap, inventory control and inventory variances affected by product and process reliability issues.
- Responsible for reviewing and approving NCR dispositions associated with standardized failure modes. Promotes recommendations for approval to the director of manufacturing engineering for non-standard or high-impact NCRs.
- Works with Program Management to maintain change logs for efficient reference during reliability investigations.
- Responsible for supporting new product launches and learning technical requirements of the product for monitoring after launch.
- Continuously improves data management and reporting of manufacturing metrics.
- Performs other duties as assigned.
- A Bachelor of Science in Biology, Chemistry, or Engineering is required to support the molecular diagnostics technical scope of this role.
- ASQ Quality engineering and/or Lean Six Sigma certification (Green or Black Belt) is preferred.
- Minimum of 2 years of experience monitoring and analyzing key metrics and leading investigations.
- Engineering experience, ideally in a manufacturing environment, is preferred.
- Ability to deduce clear and valuable information from technical information and data analysis.
- Ability to lead investigations and cross functional teams effectively.
- Uses technical writing ability to provide concise reporting and analysis.
- Must be proficient with Microsoft office applications, including Word, Excel, and PowerPoint.
- Experience with statistical analysis tools (i.e., Minitab) is preferred.
- Ability to write code and queries is preferred.
Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux 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 [emailprotected].
BioMerieux 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 BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).