We are looking for several QA Test Engineers in Minneapolis, MN. Details:
Quality Engineer - Medical/ Implantable devices
Following are must for this req.;
1. Electronic / Electrical / Mechanical / Industrial / Production engineers
2. Medical / Implantable device experience (Class 3)
3. product sterilization and bio-compatibility as they apply to quality control
• Working knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, WEEE, RoHS, and IEC 60601 standards.
• Knowledge of statistical techniques and reliability tools. Proficient with data analysis.
• Lead cross-functional design teams in the preparation of Reliability Plans for activities such as Burn-in testing, Part Stress Analysis, HALT, HASS, and Environmental Stress Screening.
• Provide reliability predictions (e.g. MTBF) for systems, subsystems, and components.
• Participate in establishing and reviewing specifications/requirements for components, products and processes. Review changes to designs and processes and assess impact to assure
• reliability requirements are met.
• Prepare, review and approve verification and qualification test protocols and reports for assigned projects. Provide well-written reports and supporting documentation.
• Evaluate field performance of assigned products by analyzing field data. Investigate and evaluate product field problems and nonconforming product. Work with suppliers to resolve
• product performance issues or failures.
• Improve data collection tools, methods and processes for generating failure rates and other product performance data.
• Participate in activities to establish and maintain the Risk Management process, including application of ISO 14971. Contribute to hazard assessments and FMEAs.
HealthcareITCentral.com - 2 years ago