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Senior Quality Assurance Engineer
2 months ago
Innovating to develop reliable solutions that identify, anticipate, and mitigate health risks.
Unleash your potential to innovate while impacting patient care. iRhythm is transforming cardiac health...
At iRhythm, we are passionate, proactive, and committed to doing what is best for our patients, healthcare providers, and colleagues. Our leadership prioritizes the well-being of iRhythm's team members and the company's mission. We thrive together, embrace transformation, and support each other. We are Thinking Bigger and Moving Faster.
Position Overview
iRhythm Technologies, Inc. is on the lookout for a talented and experienced Senior Quality Assurance Engineer to become part of our dynamic team. This position is designed for a Risk Management specialist who will contribute to the development, upkeep, and ongoing enhancement of the global medical device risk management strategies and protocols for iRhythm products and processes. This individual will be instrumental in ensuring that our products meet the highest quality standards and comply with medical device risk management regulations, including EU MDR requirements.
This role requires a hybrid work model with an in-office presence on designated days.
Key Responsibilities:
- Utilize your quality or clinical expertise in ISO 14971 to enhance the organization's understanding and application of effective Risk Management processes and methodologies.
- Lead Risk Management initiatives throughout product development (Design and Use), manufacturing processes (PFMEAs), and the post-market surveillance phase.
- Provide quality oversight to project teams regarding the Risk Management System, incorporating post-market feedback into the new product development cycle.
- Leverage your knowledge to create and maintain Post-Market Health Hazard/Risk Evaluations for all products.
- Facilitate a comprehensive Risk Management process that integrates insights from post-market surveillance into new product development, process enhancements, and clinical evaluation reports.
- Collaborate with iRhythm's clinical team, including Medical Directors, to standardize Risk Management practices across product design, manufacturing, and post-market processes.
- Represent Risk Management processes and documentation during internal and external audits.
- Stay informed about emerging regulatory and industry trends in risk management and serve as a risk management coach and trainer within iRhythm.
Qualifications:
- Bachelor's Degree in a science, engineering, or healthcare-related discipline.
- A minimum of 5 years of experience in Quality, Regulatory, or Clinical roles.
- Familiarity with Risk Management standards such as ISO 14971 and associated tools, methodologies, and processes.
- Working knowledge of ISO 13485, FDA 21 CFR 820, and European Union MDR requirements.
- Ability to build rapport across functional teams and collaborate on risk management initiatives.
- Strong attention to detail and adherence to timelines.
- Excellent verbal and written communication skills, along with strong interpersonal abilities.
- Experience with FDA inspections and Notified Body audits is preferred.
- Clinical experience or background is advantageous.
Benefits:
This is a full-time position offering a competitive compensation package and comprehensive benefits, including medical, dental, and vision insurance starting on your first day, health savings account contributions, pre-tax benefits, travel reimbursement for medical care, and non-contributory life insurance and disability coverage. Additional benefits include:
- Emotional health support for you and your family.
- Legal, financial, identity theft, and referral assistance.
- Paid parental leave, holidays, travel assistance for personal trips, and PTO.
iRhythm also offers additional perks such as a 401(k) plan with company matching, an Employee Stock Purchase Plan, discounts on pet insurance, unlimited access to LinkedIn Learning courses, and much more.
Company Overview:
iRhythm is a pioneering digital healthcare organization dedicated to creating reliable solutions that detect, predict, and prevent health issues. By combining wearable biosensors with cloud-based data analytics and advanced proprietary algorithms, iRhythm transforms data from millions of heartbeats into clinically actionable insights. With a relentless focus on patient care, iRhythm aims to provide better data, better insights, and improved health outcomes for all.
