Manager, Post Market Engineering (Onsite) Job at iRhythm Technologies, Inc., Orange County, CA

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  • iRhythm Technologies, Inc.
  • Orange County, CA

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

Job Tags

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