iRhythm Technologies, Inc. · 4 days ago
Sr. Quality Engineer - 2nd Shift
Orange County, CA
Full-time
Onsite
Mid, Senior Level
$96K/yr - $125K/yr
5+ years expiRhythm Technologies, Inc. is a leading digital healthcare company focused on cardiac health solutions. The Senior Quality Engineer plays a key role in sustaining and improving quality systems and processes within the manufacturing operations, ensuring compliance and quality support during second shift hours.
Health CareHealth DiagnosticsMedical DevicemHealthWearables
Responsibilities
Serve as second-shift quality owner for non-conformance (NCR), material review board (MRB), and batch record review activities within manufacturing and intake
Provide real-time quality support to operations, warehouse, and engineering teams during second shift to ensure uninterrupted flow of product and data
Lead or support investigations, root cause analysis, and corrective/preventive action (CAPA) implementation for product and process deviations
Support execution of equipment and process validation (IQ/OQ/PQ) for new or modified equipment and processes occurring during second shift hours
Ensure compliance with FDA 21 CFR 820, ISO 13485, and other applicable regulatory standards during second-shift activities
Maintain and report key performance indicators (KPIs) for operations quality; identify trends and lead process improvements
Participate in internal/external audits, inspection readiness, and routine walkthroughs to ensure ongoing quality and compliance
Collaborate cross-functionally with production, maintenance, supply chain, and engineering teams during the evening shift
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related technical field (required); Master's degree is a plus
5–8 years of experience in medical device manufacturing quality engineering or similar regulated industry
Deep knowledge of FDA QSR (21 CFR 820), ISO 13485, and EU MDR compliance
Experience with non-conformance management, CAPA, validation protocols, and change control processes
Skilled in problem-solving methodologies (8D, DMAIC, 5-Whys) and use of statistical tools (e.g., Minitab)
Familiarity with ISO 14971 risk management and statistical sampling approaches (e.g., AQL)
Effective communicator with ability to work independently and cross-functionally on the second shift
Highly organized and responsive to shift-based needs and priorities
Preferred
Experience with ERP and eQMS systems (e.g., QAD, Master Control)
Prior audit support experience with FDA or Notified Bodies
Quality certifications (e.g., CQE, Six Sigma Green/Black Belt) are a plus
Benefits
Medical, dental, and vision insurances (all of which start on your first day)
Health savings account employer contributions (when enrolled in high deductible medical plan)
Cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts)
Travel reimbursement for medical care
Noncontributory basic life insurance & short/ long term disability
Emotional health support for you and your loved ones
Legal / financial / identity theft/ pet and child referral assistance
Paid parental leave
Paid holidays
Travel assistance for personal trips
PTO
401(k) (with company match)
Employee Stock Purchase Plan
Pet insurance discount
Unlimited amount of LinkedIn Learning classes
Company
iRhythm Technologies, Inc.
iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease.
1001-5000 employees
H1B Sponsorship
iRhythm Technologies, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (13)
2023 (10)
2022 (9)
2021 (16)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$1.18BKey Investors
BraidwellNovo HoldingsNorwest
2024-03-04Post Ipo Debt· $643.6M
2020-08-21Post Ipo Secondary· $220M
2019-09-11Post Ipo Equity· $115M
Leadership Team
Quentin Blackford
Chief Executive Officer
Mark Day
Chief Technology Officer
Recent News
GlobeNewswire
2025-12-08
Company data provided by crunchbase