Lead Quality Assurance Engineer
2 weeks ago
Innovating boldly to develop reliable solutions that identify, forecast, and avert health issues.
Are you prepared to be part of a team committed to enhancing patient outcomes? At iRhythm, we strive to progress cardiac care, and we believe in the power of collaboration to fulfill this goal.
About The Lead Quality Assurance Engineer Position at iRhythm
iRhythm Technologies, Inc. is seeking a proficient Lead 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 operations to guarantee optimal quality and adherence to regulations.
This position operates in a hybrid model, necessitating on-site attendance at our designated office two days each week.
Core Responsibilities:
- Leverage your knowledge of ISO 14971 to enhance the organization's comprehension of Risk Management methodologies.
- Direct Risk Management initiatives throughout product development, manufacturing operations, and post-market assessments.
- Deliver quality oversight to project teams and create Post-Market Health Hazard/Risk Evaluations.
- Maintain an effective Risk Management cycle and collaborate with clinical teams.
- Represent Risk Management practices during audits and remain informed about regulatory developments.
Essential 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.
- Capability to work collaboratively across teams, meticulous attention to detail, and outstanding communication abilities.
- Experience with FDA inspections and a clinical background is advantageous.
What You Will Receive:
This full-time role provides a competitive compensation package, with medical, dental, and vision coverage commencing on the first day, employer contributions to health savings accounts, paid time off, and a variety of benefits including emotional health 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 perks.
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