Reliability Specialist

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 instrument department. This role will also lead cross-functional technical teams through business-critical failure investigations and resolutions.

Primary Duties

• 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.

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.

Training and Education

• 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.

Experience

• Minimum of 2 years of experience monitoring and analyzing key metrics and leading investigations.
• Engineering experience, ideally in a manufacturing environment, is preferred.

Knowledge, Skills, and Abilities

• 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.