Senior Quality Engineer, CSV; Non-Product

About This Role

Senior Quality Engineer for Computer System Validation (non-product) will report to the Sr. Manager, Computer System Validation (non-product) and is responsible for supporting the lifecycle management, validation, and compliance of computerized systems used in quality management, manufacturing, distribution, and business operations of iRhythm. This role ensures all such computerized systems comply with FDA 21 CFR Part 11, Part 820, ISO 13485, EU MDR, and other applicable regulations and standards.

This position is based at our manufacturing facility located in Cypress, CA, and is a full-time hybrid opportunity and will work in the office 3 days/week.

• 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.

• 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. Master Control, Veeva, Track Wise).
• 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.

This is a regular full-time position with competitive compensation package, excellent benefits including 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.

Additionally, we offer:

• emotional health support for you and your loved ones
• legal / financial / identity theft/ pet and child referral assistance
• paid parental leave, paid…