About this role:
iRhythm Technologies, Inc. is seeking a Senior Manager, Quality Assurance to lead the Post Market Complaints Document Control and QS Training functions. This role is responsible for operational execution, people leadership, and quality compliance within established corporate Quality strategies, processes, and governance frameworks.
The Senior Manager will support Quality as the Quality representative for internal and external audits and inspections and is accountable for communicating quality compliance decisions at the site and functional level, in alignment with corporate policies and escalation pathways. While functional scope remains focused on Post Market Complaints and Document Control & training, this role reflects significantly increased organizational scale, leadership breadth, and operational decision‑making accountability, including direct leadership of supervisory‑level managers.
Responsibilities:
- Provide leadership and oversight to multiple supervisory‑level leaders, with overall accountability for Complaint Investigators and Document Management Specialists.
- Establish clear expectations for performance, accountability, workload planning, and quality outcomes across teams.
- Drive talent development, coaching, succession planning, and organizational scalability to support business growth.
- Conduct annual performance reviews with regular check‑ins for Supervisors; ensure consistent performance management practices across teams.
- Serve as the primary site representative to support the Global Quality Function for internal and external quality audits and inspections, acting as the primary site interface with auditors and regulators during audits, coordinating preparation, responses, and follow‑up activities, with escalation to corporate Quality leadership as appropriate.
- Exercise independent judgment in day‑to‑day quality and compliance decisions within the scope of established corporate Quality processes; escalate high‑risk, novel, or enterprise‑impacting issues through defined governance channels.
- Ensure complaints are closed in a timely manner and that all global medical device reports are submitted within required regulatory timeframes.
- Ensure document controls and training tasks are executed in a timely manner and that all corporate requirements and documentation standards are met.
- Contribute functional and site‑level insights to support corporate Quality strategy development and continuous improvement initiatives.
- Identify opportunities to improve compliance, effectiveness, and operational efficiency; lead or support improvement initiatives within defined scope.
- Provide data, metrics, and analysis to support departmental and enterprise Quality reporting and decision‑making.
- Perform other quality and regulatory‑related duties as assigned.
Required Qualifications:
- Bachelor's Degree or Associate Degree in science, technology, or medical‑related fields.
- 10+ years of experience in Quality Assurance, preferably in Complaint Handling and/or Post Market roles within a regulated medical device environment.
- 5+ years of progressive people leadership experience, including direct management of Supervisors or Managers.
- Demonstrated experience supporting or leading regulatory inspections and audits.
- Strong working knowledge of ISO 13485, FDA 21 CFR 820, and EU MDD/MDR requirements.
- Proven ability to exercise sound judgment and make quality compliance decisions within established governance frameworks.
- Strong interpersonal, organizational, and communication skills to effectively lead teams and work cross‑functionally.
- Demonstrated critical thinking and problem‑solving skills, including investigation and resolution of complex quality issues.
- Strong technical writing skills with the ability to clearly articulate findings, conclusions, and rationale.
- Experience identifying problems and leading initiatives to improve processes, procedures, and practices.
- Proficiency with MS Word, Excel, Adobe Acrobat, and other commonly used business and quality systems.
- Ability to work effectively with minimal supervision in a highly regulated, fast‑paced environment.
This is a full‑time position. iRhythm offers a competitive salary and comprehensive benefits package.
