iRhythm Technologies, Inc. · 1 week ago
Senior Quality Engineer, CSV (Non-Product)
Orange County, CA
Full-time
Hybrid
Mid, Senior Level
$96K/yr - $125K/yr
5+ years expiRhythm Technologies, Inc. is a leading digital healthcare company focused on creating solutions that detect, predict, and prevent disease. The Senior Quality Engineer for Computer System Validation (non-product) will support the lifecycle management, validation, and compliance of computerized systems used in quality management and business operations, ensuring compliance with relevant regulations and standards.
Health CareHealth DiagnosticsMedical DevicemHealthWearables
Responsibilities
Support software lifecycle processes for non-product software in accordance with internal procedures and regulatory requirements
Ensure systems used in support of GxP activities are validated and maintained appropriately in compliance with applicable FDA, EU and other international regulations and ISO standards
Support quality risk assessment activities (e.g., system level risk assessment, functional risk assessment, change risk assessment) throughout the life cycle of computerized systems
Execute validation strategies and planning of validation activities; Oversee execution of validation activities for non-product computerized systems
Review and approve validation documentation including, but not limited to, risk assessments, validation plans, protocols (IQ/OQ/PQ), traceability matrices, and validation reports
Collaborate with IT, vendors, and functional departments to ensure systems are validated and maintained in their validated state
Maintain computer system inventory
Ensure validation documentation are retained per the company’s retention policy and retrievable
Participate in change control processes to assess impact upgrades and changes on validated systems; Oversee execution of change actions
Coordinate and execute periodic reviews of validated systems per defined schedule; support development of remediation plan, if needed
Support audits and inspections by providing validation documentation and subject matter expertise
Provide guidance on software assurance and CSV principles and procedures to cross-functional teams
Support data integrity initiatives and ensure Part 11/Annex 11 compliance of electronic records and electronic signatures
Additional responsibilities may be assigned as necessary to support the business
Qualification
Required
Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field
5+ years of experience in CSV and software assurance within the medical device, pharmaceutical, or biotech industry
Strong understanding of: 21 CFR Part 11, Part 820, ISO 13485, ISO 14971, GAMP5 guidelines, FDA guidance on risk-based software validation and computer software assurance
Proven Experience with software development lifecycle (SDLC) and Computer System Validation (CSV) documentation
Experience with validation and compliance of on-premises and cloud-based (SaaS) applications
Experience with QMS software platforms (i.e. MasterControl, Veeva, TrackWise)
Experience with ERP platforms (i.e. SAP, QAD) and other enterprise business applications supporting GxP processes
Experience with CSV and system assurance activities for Manufacturing and Laboratory systems
Detail-oriented with strong communication, technical writing and audit readiness skills
Ability to simultaneously manage multiple, cross-functional, validation projects
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
2026-01-16
Investor's Business Daily
2026-01-13
Company data provided by crunchbase