About the Role
Title: Sr. Quality Systems Engineer – CAPA
Location: Remote, US
Job Description:
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 careJoin 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 iRhythms 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
As the Sr. Quality Systems Engineer CAPA, you will be responsible for the maintenance of a robust global CAPA process across iRhythm. You will serve as one of the advocates 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 iRhythms 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 Medical Device standards and regulations.
- 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
- Support CAPA Board meetings, drive decision-making through data, and follow through on outcomes.
- Train and mentor CAPA owners in all required elements and best practices of CAPA, including use of the CAPA tool.
- Support audit program during regulatory and internal audits as it relates to CAPA files and audit readiness.
- 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:
- Bachelors Degree or the equivalent quality/regulatory experience
- Minimum of 5 years of experience in a Quality or Regulatory related role.
- Minimum of 2 years of experience with Corrective Action and Preventative Action activities, within a medical device or equivalent healthcare company.
- Must have a deep understanding of corrective and preventive actions systems and associated regulatory requirements.
- Previous experience in a medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD/MDR
- 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