Sr. Quality Engineer

IRhythm Technologies Inc.; California; On-site; USD 110,000 - 150,000; Full time

Job summary

iRhythm Technologies Inc. in Cypress, CA, is hiring a Sr. Quality Engineer to provide on-site quality engineering support for high-volume medical device manufacturing, ensuring product quality and regulatory compliance.

You will lead investigations for nonconformances, CAPA actions, change control, MRB activities, and data-driven quality improvements using SPC, Cp/Cpk, and risk management in a fast-paced environment.

Experience in FDA-regulated settings and ISO 13485 is required.

Qualifications

• Bachelor’s degree in engineering
• 5 years of Quality Engineering experience in a regulated industry
• Experience in the medical device industry
• Strong understanding of FDA-regulated manufacturing environments
• Quality System Expertise: CAPA, Nonconformance management, Change control processes, Risk management

Responsibilities

• Provide daily on-site quality engineering support to manufacturing operations.
• Partner with production teams to ensure product quality, compliance, and efficient resolution of quality issues.
• Lead investigations for nonconformances, deviations, and manufacturing quality issues.
• Apply structured root cause analysis methodologies including: 5 Why, Fishbone, Fault Tree Analysis
• Lead or support CAPA investigations and implementation.
• Analyze manufacturing data to identify trends, risks, and opportunities for improvement.
• Drive continuous improvement initiatives to enhance manufacturing process capability, product quality, and operational efficiency
• Support process validation activities (IQ/OQ/PQ) for manufacturing equipment and processes
• Review and support Engineering Change Orders (ECO) for quality impact assessment
• Ensure manufacturing quality processes align with 21 CFR 820, FDA QMSR, ISO 13485

Skills

CAPA

Nonconformance management

Change control

Risk management

FDA 21 CFR 820

ISO 13485

Statistical analysis

Process validation

Education

Bachelor’s degree in engineering

Job description

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:

Position: Sr. Quality Engineer

Reports to: Manager, Manufacturing Quality Engineering

Location: On site Cypress, CA

About this role:

The Senior Quality Engineer provides on-site quality engineering support for high-volume manufacturing operations of regulated medical devices. This role partners closely with Engineering and Operations to ensure product quality, regulatory compliance, and continuous improvement of manufacturing processes.

Responsibilities:

Manufacturing Quality Support

• Provide daily on-site quality engineering support to manufacturing operations.
• Partner with production teams to ensure product quality, compliance, and efficient resolution of quality issues.
• Participate in Material Review Board (MRB) activities and approve nonconforming product dispositions
• Represent Quality in production escalation and operational review meetings.

Nonconformance & Investigation Leadership

• Lead investigations for nonconformances, deviations, and manufacturing quality issues.
• Apply structured root cause analysis methodologies including: 5 Why, Fishbone, Fault Tree Analysis
• Ensure investigations are data-driven, thorough, and compliant with regulatory expectations.

CAPA Ownership

• Lead or support Corrective and Preventive Action (CAPA) investigations and implementation.
• Ensure robust root cause identification, corrective action effectiveness, and timely closure.
• Collaborate cross-functionally to implement systemic improvements.

Statistical Quality & Data Analysis

• Analyze manufacturing data to identify trends, risks, and opportunities for improvement.
• Utilize Statistical Process Control (SPC) and process capability analysis (Cp/Cpk) to evaluate process performance.
• Support implementation of statistical methods to improve manufacturing robustness.
• Identify opportunities for process capability improvement and defect reduction using statistical methods and structured problem-solving techniques.

Continuous Improvement & Operational Excellence

• Drive continuous improvement initiatives to enhance manufacturing process capability, product quality, and operational efficiency
• Analyze production and quality data to identify systemic issues, trends, and improvement opportunities
• Lead cross-functional problem-solving activities to reduce defects, scrap, rework, and recurring nonconformances
• Partner with Operations and Engineering teams to implement process improvements and mistake-proofing (poka-yoke) solutions.
• Support initiatives to improve manufacturing yield, process stability, and overall product quality performance.
• Monitor and report quality metrics and process performance indicators to drive data-informed decision making.

Process Validation Support

• Support process validation activities (IQ/OQ/PQ) for manufacturing equipment and processes.
• Review and approve validation protocols and reports.
• Ensure validation documentation meets regulatory and internal quality requirements.

Change Control & Risk Management

• Review and support Engineering Change Orders (ECO) to ensure appropriate quality and regulatory impact assessment
• Ensure risk management activities align with ISO 14971 requirements.
• Provide quality input during manufacturing and process changes

Quality Systems Compliance

• Ensure manufacturing quality processes align with 21 CFR 820, FDA QMSR, ISO 13485
• Support internal audits, regulatory inspections, and compliance initiatives as needed.

Required Qualifications:

Education

• Bachelor’s degree in engineering (Mechanical, Biomedical, Electrical, Industrial)

Experience

• 5 years of Quality Engineering experience in a regulated industry
• Experience in the medical device industry required
• Strong understanding of FDA-regulated manufacturing environments
• Quality System Expertise: Demonstrated experience with: CAPA, Nonconformance management, Change control processes, Risk managemen