Quality Systems Engineer Lead

iRhythm Technologies•San Francisco, CA

48d•Hybrid

About The Position

The Quality Systems Engineer Lead is responsible for leading the implementation and continuous improvement of the Quality Management System, ensuring that Quality System processes effectively support compliance and business strategy across all regulated markets. This position helps to ensure the organization maintains a compliant, data-driven, and effective Quality Management System (QMS). The individual will serve as a subject matter expert (SME) within the QMS and will partner cross-functionally with Quality, Regulatory, Operations, Engineering and Clinical teams to ensure alignment with FDA 21 CFR Part 820, ISO 13485, EU MDR 2017/745, UK MDR 2002, and Japan MHLW/PMDA QMS Ordinance requirements.

Requirements

Bachelor's Degree or equivalent experience.
Minimum of 8 years of experience in a Quality or Regulatory role, preferably in medical devices with at least 6 years of experience working in the Quality System.
Direct experience in Quality System processes 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 resource 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.

Responsibilities

Lead Projects that are related to improving the Quality System
Collaborate on the implementation of strategies for Quality improvement processes
Interpret and communicate trends, must have basic knowledge of statistical techniques
Must be well-versed with Quality System Regulations
Work with stakeholders and other business leaders to identify opportunities for improvement based on data insights
Identify detailed customer requirements, constraints, and assumptions with stakeholders to establish project deliverables.
Drive the identification, assessment, monitoring, and resolution of project risks.
Manage QMS activities to support the achievement of project milestones.
Partners with key stakeholders to define actions and plans to develop and maintain a high-performing, scalable, and compliant Quality System.
Translate data and trends into actions to drive business decisions
Help identify product trends and drive actionable insights.
Extract and format data from various systems per the respective processes
Develop and optimize methods to visualize data (Tableau dashboards, charts, presentations, etc.)
Work together with teams across all levels of the organization
Aid in coordination and support of e-QMS upgrades, software tool upgrades, and improvement initiatives in relation to Quality System IT infrastructure
Lead and/or support of the investigation of complex quality issues
Lead workstream integration and remediation of Quality System policies and procedures as assigned.
Conduct gap assessments and implement necessary process changes with subject matter experts.
Engages in continuous improvement activities by identifying opportunities and recommending improvements to processes across iRhythm.
Other related duties as may be assigned.