iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining our wearable biosensing technology with powerful cloud-based data analytics and machine- learning capabilities. Our goal is to be the leading provider of first-line ambulatory ECG monitoring for patients at risk for arrhythmias. iRhythm’s continuous ambulatory monitoring has already put over 1 million patients and their doctors on a shorter path to what they both need – answers.
About this role:
Responsible for assuring projects meet customer expectations, and regulatory requirements including FDA Quality System Regulations 21CFR Part 820, Medical Device Directive (MDD) 93/42/EEC, Canada Medical Devices Regulations (CMDR) (SOR/98?282) and Risk Management per ISO 14971.
Additional responsibilities include:
Applies knowledge of IEC 60601?1 Medical Electrical Equipment and collateral standards, IEC 62366 Usability, and IEC 62304 Software Lifecycle to product development and sustained engineering projects
Serves as a Quality Assurance representative on one or more project teams engaged in new product development, quality processes improvements, business system implementations or other special projects
Applies knowledge in Quality Systems to execute overall project assignments
Applies statistical tools to analyze data and identify root cause and problem resolution
Identifies and routinely uses the most effective, cost-efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
Reviews and approves product documentation, drawings, process and design verification/validation
Serve as a technical resource for assessing validation requirements, solving test related problems, and developing preventive strategies
Perform and lead risk assessment exercises in support of validation activities
Plans, develops, implements, and maintains the document change control system.
Consider the application of privacy, security, environmental, health, and safety standards.
Assist and participate in internal and external audits, including supplier audits.
Produce technical reports to support product changes or quality assurance investigations.
Perform other quality?related duties as assigned
What’s in it for you:
This is a full-time position with competitive salary package and excellent benefits including medical, dental and vision insurance, paid holidays and paid time off.
iRhythm also provides additional benefits including 401K (w/ company match), an Employee Stock Purchase Plan, annual organizational/cultural committee events and more!
FLSA Status: Exempt
Rhythm Technologies, Inc. is an Equal Opportunity Employer (M/F/V/D).
Bachelor’s Degree in an applied science or engineering field.
5?7 years of experience in Quality Assurance of class II or III with embedded software in the medical device field.
Demonstrated competency of 21 CFR 820, MDD/CMDR, ISO13485, ISO 14971, HIPAA and other international standards.
Exceptional problem?solving skills.
Understands and can subsequently explain complex quality details to non?experts.
Exceptional organizational skills.
Willingness to travel when required, approximately 20%.
Knowledge and experience with ERP/MRP systems and their applications.
About iRhythm Technologies
iRhythm is a digital healthcare company redefining the way cardiac arrhythmias are clinically diagnosed by combining our wearable biosensing technology with cloud-based data analytics and machine- learning capabilities. Our goal is to be the leading provider of first-line ambulatory electrocardiogram, or ECG, monitoring for patients at risk for arrhythmias.
We have created a unique platform, ZIO by iRhythm, which we believe allows physicians to diagnose many arrhythmias more quickly and efficiently than traditional technologies, avoiding multiple indeterminate tests, allowing for appropriate medical intervention and potentially avoiding more serious downstream medical events, including stroke