Job Description

About this role:

iRhythm Technologies, Inc. is looking for a Manager, Post Market Engineering to join the Quality team. The Post Market Engineering Manager will oversee the Post Market Quality Engineering team to ensure compliance, accuracy, and efficiency, including oversight over a Complaints Lab. The position will also provide data and analysis to support Quality department as needed.

Responsibilities:

• Provide supervision and leadership to a team of Quality Engineers and Complaints Technicians.
• 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
• Establish and maintain documented laboratory procedures
• Manage and update testing methods, techniques and equipment, as needed
• Review investigated complaints to ensure procedural and regulatory compliance.
• Ensures complaints are closed in a timely manner, ensures all global medical device reports are submitted within regulatory timeframes.
• Manages projects associated with the Complaint Handling process
• Participates in process improvements to improve compliance, effectivity, and efficiency, and takes ownership for updating procedures and policies.
• 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 and / or a complaint processing role, experience with Medical Device Reporting.
• Supervisory or Manager experience 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.

Work Environment

• Onsite - Cypress, CA

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