Description
POSITION SUMMARY:- Ensure Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Familiarity with ISO 14971, Risk Management for medical devices.
- Participate in the development and results analysis of validation plans (IQ/OQ/PQ) and test protocols to qualify and validate existing and new product designs and processes. Includes the use of various statistical techniques and quality tools.
- Experienced with statistical techniques, including design of experiments (DOE); able to analyze results.
- Determines and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will assure specific quality levels.
- Develop validation strategies so that all appropriate requirements are being met from planning, protocol definition, leading execution of protocol, analyzing and reporting results and defining procedures and training requirements, completing report and gaining approval to close
Education/Experience Necessary:
- Minimum of 5 years as an Engineer in the related field.
- BS in Mechanical Engineering, Biomedical Engineering, Process Engineering, Analytical Chemistry, or related technical discipline, preferred.
- Solid experience in Risk Management for medical devices ISO 14971 desired
- Application and leading problem-solving, root cause analysis and related Corrective and Preventive Action
- Statistical analysis, JMP software preferred
- Proficient in the use of various measuring tools and troubleshooting equipment