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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.
- 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.
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.
- ASQ Quality engineering certification is preferred.
- Experience with IVD molecular devices is preferred.
- 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.
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. 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 BioFire Diagnostics’ 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).