Title: Staff Quality Engineer – Global Risk Management
Location: Remote, US
iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining our wearable bio sensing technology with powerful cloud-based data analytics and Artificial Intelligence capabilities. Our goal is to be the leading provider of ambulatory ECG monitoring for patients at risk for arrhythmias. iRhythm’s continuous ambulatory monitoring has already put over 2 million patients and their doctors on a shorter path to what they both need answers.
About this role:
iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining our wearable bio sensing technology with powerful cloud-based data analytics and Artificial Intelligence capabilities. Our goal is to be the leading provider of ambulatory ECG monitoring for patients at risk for arrhythmia’s. iRhythm’s continuous ambulatory monitoring has already put over 4 million patients and their doctors on a shorter path to what they both need answers.
This role is for a Risk Management expert, who would be assisting in the development, maintenance and continuous improvement of the global medical device risk management strategies and procedures for iRhythm products and processes. This individual will play a key role in achieving products of the highest quality and maintain regulatory compliance to medical device risk management standards and regulations, including the EU MDR requirements.
This role supports various U.S. and UK iRhythm sites and may require approximately 10% travel. The role may be remote or based in San Francisco or Cypress, CA.
- Your quality or clinical background and expertise in ISO 14971 will be utilized to strengthen the Organizational understanding and importance of applying proper Risk Management processes and techniques.
- You will lead Risk Management activities within product development (Design and Use), manufacturing processes (PFMEAs), and the post-market surveillance phase.
- You will provide quality oversight to project teams in terms of the Risk Management System, including post-market information of similar products’ feedback into the new product development cycle.
- Your knowledge will be utilized to develop and maintain Post-Market Health Hazard/Risk Evaluations across all products.
- You will lead activities to maintain a closed-loop Risk Management process that incorporates information obtained from post-market surveillance into new product development, process improvements, and clinical evaluation reports.
- You will interface with iRhythm’s clinical team, including Medical Directors as necessary, to standardize Risk Management approach across product design, manufacturing, and post-market surveillance processes.
- You will represent Risk Management processes and documents during internal and external audits.
- You will keep abreast of emerging regulatory and industry trends regarding risk management and act as the risk coach and trainer within iRhythm.
- Assist post-market quality team with optimizing product investigation process.
- Bachelor’s Degree in science, engineering, or healthcare related field.
- Minimum of 8 years of experience in Quality, Regulatory, or Clinical related role.
- Experience with Risk Management standards such as ISO 14971 and Risk Management tools, methodologies, and processes including use of a variety of accepted methods.
- Working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDR requirements.
- Must build rapport across functional teams within the organization and collaborate on risk management activities
- Attention to detail and timeliness are critical
- Excellent communication (verbal and written) and interpersonal skills required
- Direct exposure to FDA inspections and Notified Body audits preferred
- Clinical experience or background preferred
What’s in it for you:
This is a full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurance (all of which start on your first day), paid holidays, and PTO!
iRhythm also provides additional benefits including 401K (with company match), an Employee Stock Purchase Plan, paid parental leave, pet insurance discount, Cultural Committee/Charity events, and so much more!
FLSA Status: Exempt
As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer (M/F/V/D). Pursuant to San Francisco Fair Chance Ordinance, we will consider for employment all qualified applicants with arrest and conviction records.
Make iRhythm your path forward.