Abbott R&D IACC Risk Management Integrator in Irving, Texas
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Defines and documents critical performance requirements that link to system design across interacting functions, (i.e., hardware, software,labeling and/or assay) · Identifies, confirms and interprets interacting causes & effects behind instrument issues, discrepancies, problems or complaints in accordance with governing procedures · Devises root cause hypotheses and confirms instrument issues, discrepancies, problems or complaints in accordance with governing procedures. · Develops or provides input into moderate complexity project plans and timelines. · Develops and executes system related (i.e., hardware, software,labeling and/or assay) verification & validation and/or characterization protocols and develops and interprets complex written data package summaries in accordance with governing procedures · Defines investigative paths for and confirms Complaint Handling investigations to closure.
Writes and executes moderately complex system related (i.e., hardware, software, labeling and/or assays) verification and/or characterization protocols including acceptance criteria, analyzes data, write data summaries in accordance with governing procedures.
Advanced troubleshooting of customer complaints in accordance with governing procedures.
Advanced troubleshooting across multiple system functions (hardware and software or hardware and assay performance problems).
Advanced proficiency in operation of instrument, software operating systems, and repair/replacement of parts/subassemblies.
Responsible for implementing and maintaining the effectiveness of the ADD quality system.
Applies quantitative methods, analyzes data, evaluates results, forms conclusions and provides/implements improvements.
Bachelors degree in Life Science or closely related discipline is desired; or or relevant combination of education or expeirence. · 4-6 years work related experience. · Knowledge of external regulations and standards affecting IVDs and Biologics. · Good Lab Practice, PC Skills (Word, Excel, Powerpoint); Data representation · Reviews, generates and documents Verification & Validation or characterization related inputs. · Demonstrates use of statistics, Design of Experimentation, Six Sigma method, FEMA Cause and Effect or Fishbone Diagram, DOORS, Excel, Powerpoint, Word. ID Critical Performance Requirements Based on Customer Needs (QFD, benchmarking) · Optimizes processes: set targets, ranges and specs - DOE, Guard band, Tolerance analysis, Capability (CPk), Test Method development, determine manufacturability / FPA · Presents, delivers and interprets information amongst product team members, scientists, engineers, and other systems development personnel. · Moderate knowledge of external regulations and standards affecting IVDs and Biologics. · Proficient in operation of instruments and repair/replacement of parts/subassemblies. · Proficient in moderately complex Project management.
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Abbot welcomes and encourages diversity in our workforce.
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