Senior Quality Engineer, CSV (Non-Product) at iRhythm Technologies

California, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

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

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

Skills

Computer System Validation

CSV

21 CFR Part 11

21 CFR Part 820

ISO 13485

EU MDR

FDA Compliance

Software Lifecycle

Quality Management

GxP

iRhythm Technologies

Advanced cardiac monitoring solutions provider

About iRhythm Technologies

iRhythm Technologies focuses on cardiac monitoring solutions, with its main product being the Zio Patch, a wearable device that tracks heart rhythms for up to 14 days. This extended monitoring helps healthcare providers detect irregular heart rhythms that shorter monitoring might miss, making it especially useful for patients at risk. The company serves both patients and healthcare providers, generating revenue by selling the Zio Patch and offering data analysis services to interpret the collected heart data. iRhythm aims to improve patient outcomes and streamline healthcare workflows in the cardiac health sector.

San Francisco, CaliforniaHeadquarters

2006Year Founded

$102.8MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees