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Sr. Quality Engineer - 2nd Shift

iRhythm Technologies, Inc.

California

On-site

USD 96,000 - 125,000

Full time

30+ days ago

Job summary

Join a leading digital healthcare company as a Senior Quality Engineer based in California, where you'll support quality systems in medical device manufacturing. This full-time position focuses on non-conformance investigations, process validations, and compliance with FDA standards, offering competitive pay and benefits.

Benefits

Medical, dental, and vision insurances

Health savings account employer contributions

401(k) with company match

Employee Stock Purchase Plan

Unlimited LinkedIn Learning classes

Paid parental leave

Travel assistance for personal trips

Qualifications

5–8 years of experience in medical device manufacturing quality engineering.
Deep knowledge of FDA QSR (21 CFR 820) and ISO 13485 compliance.
Experience with CAPA and validation protocols.

Responsibilities

Lead investigations, root cause analysis, and CAPA implementation.
Ensure compliance with regulatory standards during second-shift activities.
Provide real-time quality support to operations during the second shift.

Skills

Problem-solving methodologies

Quality Engineering

Statistical tools

Effective communication

Education

Bachelor’s degree in Engineering

Master’s degree

Tools

Minitab

ERP systems

eQMS systems

Career-defining. Life-changing.

At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

About This Role:

Boldly innovating to create trusted solutions that detect, predict, and prevent disease.

Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care…Join Us Now!

At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and committed to iRhythm’s employees and the mission of the company. We are better together, embrace change and help one another. We are Thinking Bigger and Moving Faster.

About This Role

The Senior Quality Engineer (Manufacturing Operations – 2nd Shift) plays a key role in sustaining and improving quality systems and processes across iRhythm’s Cypress manufacturing and intake operations. This individual will work full-time during second shift hours to ensure continuity of Quality Engineering support for late-shift manufacturing, intake, and warehouse operations. Responsibilities include leading non-conformance investigations, supporting process validations, and driving quality improvements to meet operational and compliance objectives.

Key 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.

Qualifications

About You:

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 Skills

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.

Work Environment

On-site at our Cypress, CA manufacturing facility.
Full-time, 2nd shift (Monday–Friday, approx. 2:00 PM to 10:30 PM).
Travel up to 10% may be required to support audits or cross-site quality activities.

What’s In It For You:

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 holidays, travel assistance for personal trips and PTO!

iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of LinkedIn Learning classes and so much more!

FLSA Status: Exempt

As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com

About IRhythm Technologies

iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.

Location:

Orange County

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range

$96,000.00 - $125,000.00

As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com

About IRhythm Technologies

iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.

Seniority level