About this role:

The Staff Quality Engineer will work on site in Cypress, CA and will oversee quality in Operations ensuring product is manufactured and data processed per applicable approved and released procedures, specifications, industry standards, and regulatory requirements. This individual will also be responsible for continuous improvement activities through cross-functional collaboration with other teams including Manufacturing Engineers and Production Supervisors.

The iRhythm work environment is a fast-paced, innovative, and collaborative atmosphere. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient experience.  We put the patients we serve first in everything we do.  We are looking for like-minded individuals to join our team today!

Responsibilities

• Provide technical Quality Engineering support to ensure product is manufactured and shipped per applicable requirements and standards
• Provide technical Quality Engineering support to ensure data is processed per applicable requirements and standards
• Collaborate with Engineering and Manufacturing functions to ensure quality standards are in place
• Investigate product and process non-conformances including manufacturing related complaints to determine root cause, and identify and implement preventive and corrective actions
• Review and approve product and process nonconformances dispositions; and ensure that preventive and corrective measures are effective, and that documentation is compliant with requirements.
• Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions.
• Provide support for Corrective and Preventive Actions (CAPA)
• Conduct Operations quality assessments to identifying manufacturing or data extraction process risks and work with cross-functional partners to ensure controls are in place to eliminate or reduce those risks
• Support risk management activities
• Lead and actively participate in continuous improvement activities
• Evaluate changes routed through change control system to ensure that equipment, systems, products, processes, and facilities remain in qualified, validated state.
• Assist in developing, writing, and executing protocols TMV/IQ/OQ/PQ
• Review and approve protocols and reports (TMV/IQ/OQ/PQ)
• Apply knowledge of design control principles, process & systems validation, statistical tools, and quality engineering tools (i.e., Ishikawa Diagram, Pareto chart, Control chart, Flow chart, etc.) to analyze data and drive effective problem resolution
• Provide support during  inspections (FDA, Notified Body (ISO) and other regulatory agencies).
• Perform other quality-related duties as assigned

Required Qualifications:

• Bachelor’s degree in engineering or related technical discipline with minimum of 8 years of relevant experience in Engineering and/or Quality or advanced degree in Engineering, Science, or technical field with minimum 5 years of relevant work experience in Quality and/or Engineering
• Medical device experience or experience in regulated environment
• Working knowledge of medical device regulations (21 CFR 820, ISO 13485 & 14971)
• Prior experience or good understanding of Automation Equipment including OT networks, PLCs, SCADA and SQL server applications.
• Experience with quality tools and process improvement techniques
• Excellent leadership skills, communication, and presentation skills
• Excellent technical writing skills
• Excellent analytical and problem-solving skills

Preferred Skills

• Previous experience with Automated Equipment in a Manufacturing environment
• Previous experience or good understanding of data acquisition capabilities from machine PLC and controls to drive predictive maintenance, real-time monitoring, and overall operational intelligence
• Degree in Systems Engineering, Computer Science, Software Engineering, or Electrical Engineering
• High attention to detail and accuracy
• Practical Knowledge of project management
• Proficiency with Excel & analytics software such as Minitab
• Proficiency with Risk Management tools
• ASQ CQE, Six Sigma Green Belt or equivalent certifications