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Reliability Specialist

Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Manufacturing

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.

Description

Position Summary

The Reliability Specialist is responsible for overseeing data monitoring, data reporting, investigations, and action plans for product and process performance within the BioReagents department. This role will also lead cross-functional technical teams through business-critical failure investigations and resolutions.

 

Responsibilities

  • Perform all work in compliance with company quality procedures and standards.
  • Directs cross-functional teams through CAPA and complaint 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 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 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.

 

Supplemental Data

This role is responsible for monitoring critical technical and quality data directly tied to product reliability. The ability to lead teams quickly and efficiently through investigations and create action plans to correct performance is critical to quality, availability, and cost of our products.

 

Studies and Experience

  • A Bachelor of Science in Biology, Chemistry, or Engineering is required to support the molecular diagnostics technical scope of this role.
  • AAQ Quality engineering certification is preferred.
  • Experience with IVD molecular devices is required.
  • Minimum of 2 years of experience monitoring and analyzing key metrics and leading investigations.

 

Skills and Qualifications

  • 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.
  • 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 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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