Staff Quality Engineer - Corrective & Preventive Actions

About This Role

As the Staff Quality Systems Engineer - CAPA you will be responsible for maintaining a robust global CAPA process across iRhythm. You will serve as an advocate for cross functional collaboration, continuous improvement, and compliance, with the responsibility of driving excellent quality system CAPA process performance globally. This role will work closely with cross-functional CAPA owners to provide training, guidance, and review of CAPA investigations and phases. In this role you will have the opportunity to impact product and process quality and regulatory compliance at iRhythm.

In iRhythm’s fast growing environment you will have the opportunity to enhance your technical skills and leadership competencies and advance your career.

This role supports various U.S. and UK iRhythm sites and may require 15% travel.

Responsibilities:

• Ensure the CAPA system is compliant with U.S. and applicable international standards/regulations, including ISO 13485, ISO 14971, and EU MDR requirements.
• Chair CAPA Board meetings, drive decision making and follow through on outcomes
• Work alongside CAPA owners and stakeholders on assessing issue descriptions and ensuring containment, root cause analysis, correction, corrective and preventive actions, and effectiveness checks are appropriate, of high quality, and timely.
•  Train and mentor CAPA owners in all required elements and best practices of CAPA, including use of the CAPA tool.
• Represent CAPA program, system and individual CAPA records during regulatory and internal audits.
• Maintain the quality and compliance of CAPA system records to ensure audit-readiness for internal and external quality system audits.
• Produce, analyze, and present trend metrics and reports and establish further actions as needed.
•  Engage in continuous improvement of the CAPA program by identifying opportunities and recommending actions.

Required Qualifications:

• Bachelor’s Degree or the equivalent quality/regulatory experience
• Minimum of 6 years of experience in a Quality or Regulatory related role.
• Minimum of 4 years of experience with Corrective Action and Preventative Action activities, within a medical device or equivalent healthcare company.
• Must have a deep understanding of the CAPA system and associated regulatory requirements.
• Previous experience in a medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD/MDR
• Minimum of 2 years of experience participating in regulatory audits in the front room and back room.
• Strong investigational and problem-solving skills
• Must build rapport across functional teams within the organization and have the ability to work comfortably at all levels within the organization
•  Attention to detail and timeliness are critical
•  Excellent communication (verbal and written) and interpersonal skills required
• Basic statistical methods including trend analysis

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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