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Senior Quality Assurance Engineer
2 months ago
Innovating with integrity to develop reliable solutions that identify, forecast, and avert health issues.
Are you prepared to be part of a team that is passionate about enhancing patient outcomes? At iRhythm, we are dedicated to improving cardiac health, and we believe in the power of collaboration to fulfill this goal.
About the Senior Quality Assurance Engineer Position at iRhythm
iRhythm Technologies, Inc. is seeking a proficient Senior Quality Assurance Engineer to become a vital member of our energetic team. This role emphasizes expertise in Risk Management, tasked with formulating and refining comprehensive medical device risk management strategies and protocols for iRhythm products and processes, ensuring top-tier quality and adherence to regulatory standards.
This position offers a hybrid work model, requiring in-office attendance at our Cypress, CA location two days per week.
Key Responsibilities:
- Leverage your knowledge of ISO 14971 to enhance the organization’s comprehension of Risk Management methodologies.
- Oversee Risk Management initiatives throughout product development, manufacturing operations, and post-market evaluations.
- Provide quality assurance oversight to project teams and create Post-Market Health Hazard/Risk Assessments.
- Maintain an effective Risk Management cycle and collaborate with clinical teams.
- Represent Risk Management practices during audits and keep abreast of regulatory developments.
Required Qualifications:
- Bachelor's Degree in a relevant discipline.
- A minimum of 5 years of experience in Quality, Regulatory, or Clinical functions.
- Expertise in ISO 14971, Risk Management instruments, ISO 13485, FDA regulations, and EU MDR standards.
- Strong collaborative skills, meticulous attention to detail, and exceptional communication abilities.
- Experience with FDA inspections and a clinical background is advantageous.
What You Will Receive:
This full-time role provides a competitive salary package, comprehensive medical, dental, and vision coverage from day one, employer contributions to health savings accounts, paid time off, and a variety of benefits including emotional wellness support, legal and financial assistance, paid parental leave, and more. Additionally, we offer a 401(k) plan with company matching, stock purchase options, pet insurance discounts, LinkedIn Learning opportunities, and other valuable perks.
