About this role:
iRhythm Technologies, Inc. is looking for a Manager, Quality Assurance to join the Quality team. The Manager will oversee the Post Market Complaints and Document Management team to ensure compliance, accuracy, and efficiency. The Manager will provide instruction and feedback to the team as needed. The position will also provide data and analysis to support Quality department as needed.
Our work environment is a fast-paced atmosphere, fostering excellent cross-functional collaboration. 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 who are quality driven and patient focused to join our team!
Responsibilities:
- Provide supervision and leadership to team of Complaint Investigators and Document Management Specialists
- Manage and balance assignment of work to team to meet goals.
- Provide guidance, development and performance feedback and opportunities for growth through regular one-one-one and team meetings.
- Annual Performance reviews with quarterly check-ins
- Review investigated complaints to ensure procedural and regulatory compliance.
- Manages and responds to regulatory body inquiries relating to reported complaints.
- Ensures documents are managed in a timely manner, ensuring all procedural requirements are met
- Ensures complaints are closed in a timely manner, ensures all global medical device reports are submitted within regulatory timeframes.
- Participates in process improvements to improve compliance, effectiveness, and efficiency.
- Perform other quality and regulatory-related duties as assigned.
Required Qualifications:
- Bachelor's Degree or Associate Degree in science, technology, or medical fields.
- 8+ years of experience in Quality Assurance, preferably in Complaint Handling and/or Post Market roles.
- 2+ years of experience as a Manager or Supervisor in a medical device company.
- Strong working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR.
- Strong interpersonal and organizational skills to enable working cross-functionally within the organization.
- Strong problem-solving skills, critical-thinker, and experience at investigating and resolving complex issues.
- Understand basic principles of good technical writing skills and be able to articulate findings and formulate conclusions.
- Identify problems and lead projects to improve processes, procedures and/or practices; recommend and resolve solutions.
- Excellent communication (verbal and written) and interpersonal skills required.
- Demonstrated experience with MS Word, Excel, Adobe Acrobat, and other commonly used software systems.
- Must be able to work under minimum supervision and in a team environment.
