Quality Engineer

About This Role

iRhythm is currently seeking a Quality Engineer responsible for the coordination of product and process changes for Quality System Compliance activities, supporting equipment management, laboratory compliance and audit readiness at iRhythm Technologies. In this role, you will champion a quality culture mindset by driving company-wide operational excellence and quality awareness. 

Responsibilities include ensuring Quality System compliance and identifying and implementing Quality System process improvements. This role will work cross-functionally with Product Development, Manufacturing Engineering, Quality, Regulatory, and Marketing to ensure that iRhythm operates a robust Quality System while maintaining substantial compliance to applicable US and international medical device regulations and guidelines. Our work environment is fast-paced, with a collaborative atmosphere. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient experience. We are looking for like-minded individuals to join our team today!

The Quality Engineer will report to the Manager of QMS Document Management and Training within the Quality Systems group. The role will work in close collaboration with Document Control, Training, Quality Control, Design Quality and Engineering Lab Manager.

This position is based at our R&D Headquarters located in San Francisco, CA, and is a full-time hybrid opportunity and will work in the office 3 days/week.

Specific job responsibilities include:

• Ensure iRhythm’s Quality System is compliant with internal procedures and applicable international standards/regulations
• Oversight of the change management process, including coordination of changes, review of changes, managing stakeholders and timely deliverables
• Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS expectations.
• Navigate through complex change review discussions, facilitating to a common decision for each change regarding approach and follow-up actions to be taken, and documenting the decisions and evaluations accordingly
• Review and approve equipment calibration and preventive maintenance records
• Support non-conformance investigations and quarantine out of tolerance/damaged equipment
• Review and approve nonconformance dispositions and ensure that preventive and corrective measures are effective
• Perform and coordinate regular assessment of the engineering laboratory spaces
• Quarantine nonconforming material and ensure nonconformances are initiated
• Engage in continuous improvement activities by identifying opportunities and driving improvements to processes across the company.
• Receive, inspect, and process materials for formal verification and validation activities in the ERP
• Initiate and execute Quality Plans related to changes affecting the Quality System.
• Analyze business processes and responsibilities to identify opportunities for continuous improvement
• Provide guidance and support to project teams on change management principles, methodologies, and best practices.
• Foster a culture of continuous improvement and change readiness within the organization.
• Stay updated on industry trends and best practices in change management and apply them to enhance organizational change capabilities.
• Work with the eQMS team to implement changes for the process
• Provide support during inspections (FDA, Notified Body (ISO) and other regulatory agencies).
• Perform Internal Audits and assist in maintaining a constant state of inspection readiness at the San Francisco site.

About you:

• Bachelor’s Degree or equivalent quality/regulatory experience with medical devices.
• Minimum of 2 years of experience in a Quality Assurance in the Medical Device Industry.
• Must have a deep understanding of medical device Quality Management Systems and associated regulatory requirements.
• Experience in coordination and controlling equipment calibration and Preventive Maintenance.
• Ability to adapt to a fast-paced and evolving environment.
• Previous experience in a medical device manufacturing setting with working knowledge of ISO 13485, 21 CFR 820 and ISO 14971
• Ability to read and comprehend drawings, diagrams, and work instructions.
• Experience with various hand tools like micrometer, height gauge, drop gauges, etc.
• Strong understanding of GD&T.
• Will need to demonstrate the ability to manage multiple changes of varying complexity and scope of tasks in a fast-paced environment to meet timelines.
• Demonstrates Project Management abilities to lead and manage several projects, meeting deadlines and use critical thinking skills to problem solve effectively.
• Demonstrates strong interpersonal skills with ability to influence, negotiate, manage conflict, and negotiate.
• Demonstrates excellent verbal and written communication skills to all levels of the organization. Technical writing skills required.
• Strong investigational and problem-solving skills
• Must build rapport across functional teams within the organization.
• Attention to detail and timeliness are critical.

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 Linked In Learning classes and so much more! 

FLSA Status: Exempt

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