Senior Manager, Capa

About This Role

iRhythm Technologies, Inc. is a publicly held (Nasdaq: IRTC) medical device and healthcare information services company with a proven approach to long-term continuous monitoring that enables diagnosis earlier in the clinical pathway to improve patient outcomes and reduce healthcare costs. iRhythm provides a competitive compensation and benefits package.

The Sr. CAPA Manager will provide Corrective and Preventive Action (CAPA) process leadership, with emphasis on driving process improvements, and appropriate addressing of issues escalated to the CAPA process. The Sr. CAPA Manager is responsible for training, scheduling, and performance management of the Corrective and Preventive process at all iRhythm sites. The Sr. CAPA Manager is responsible for change implementation and optimization of the CAPA, including root cause analysis process globally. This person will be the go-to person for all CAPA-related activities for the company.

The Sr. CAPA Manager will lead projects associated with global process harmonization to ensure a fully compliant and efficient CAPA system

Responsibilities:

• Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits.
• Primarily responsible for managing all Corrective Actions & Preventive Actions (CAPA) for iRhythm.
• Manages the CAPA Process: Responsible for all CAPA related activities including effective implementation of changes/ improvements to the system, regularly providing reports on the CAPA system, providing guidance cross-functionally to CAPA owners and approvers, and assessing complex investigations and corrective actions.
• Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through the implementation of actions and effectiveness monitoring.
• Lead projects related to improvements to the CAPA process: Author documentation of project plans and provide project and compliance guidance to project teams.
• Ensure CAPA records are complete. Ensure CAPA actions are robust and executed with the appropriate sense of urgency ensuring the CAPA records meet all requirements.
• Develops and maintains metrics for CAPA System, leads CAPA Review Board meetings, and may present CAPA-related metrics at Management Review.
• Leads and participates in process improvement activities that may be departmental or company-wide.
• Leads, mentors, and motivates CAPA team staff for success, provides coaching and development based on development needs for CAPA team members.
• Collaborates with leadership team and cross-functional teams.
• Maintains QMS processes that are robust, in alignment with corporate policies and procedures, and executed properly across all iRhythm sites.
• Other duties may be assigned as deemed necessary by management.

Required Qualifications:

• Bachelor's Degree or equivalent experience.
• Minimum of 10 years of experience in a Quality or Regulatory role, preferably in medical devices with at least 6 years of experience working in the CAPA system.
• Direct experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, implementing actions and project management.
• Strong leadership presence with excellent communication (verbal and written) and interpersonal skills required
• Experience managing team projects, including experience as an active contributor on projects with scheduled deliverables.
• Ability to manage complexity, analytical, and people management on a global basis.
• Strong working knowledge of GxPs, ISO 13485 and 14971 and FDA and EU MDR regulations
• Strong analytical skills with demonstrated ability to troubleshoot complex process issues.
• Attention to detail and timeliness are critical.
• Able to provide quality service cross-functionally
• Ability and willingness to coach, mentor, and train employees
• Must operate through collaboration and transparency.
• Must be a positive and energetic leader who is motivated to develop and grow a team with integrity.

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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