Quality Project Manager

Purpose and Scope

This role leads cross functional teams that are responsible for improving or remediating Monteris Quality Systems and/or Products. 

Primary Organization Responsibilities

  • Serving as Project Manager to ensure project schedules, budget, scope and risks are identified, planned and managed as appropriate. 
  • Leads execution in compliance with Monteris CAPA procedure (root cause analysis, corrective and preventive action planning, solution development, execution, and verification).
  • Synthesizes non-conformances and utilizes root cause analysis tools in order to identify systematic root causes of Monteris product and/or processes.
  • Manages manufacturing equipment maintenance and calibration.
  • Develops and implements manufacturing validations, inspections, and final lot release procedures including sterilization.

Personal Qualifications and Experience Education/Experience

Education/Experience

  • Bachelor’s engineering degree required
  • Master’s in project management or Business Administration required.
  • Certification in Project Management Professional (PMP) by Project Management International required.
  • American Society of Quality certification Quality Engineering and/or Six Sigma Green Belt required.
  • Minimum of 5 years of medical device development and/or manufacturing with specific experience in Class 2/3 devices.
  • Experience working with thermal ablation medical devices strongly preferred
  • Demonstrated expertise in utilizing MS Project with Prochain project management software.
  • Experience in supporting medical devices in the post market setting including post-market surveillance, returned product complaint analysis, manufacturing support including management of non-conforming materials, trending analysis such as complaint data and scrap analysis trending is required.

Skills/Abilities

  • Strong leadership, organizational and communication skills
  • Ability to perform in a constantly fluctuating and fast paced environment.
  • Ability to work with teams to create a work breakdown structure
  • Ability to facilitate development of a network diagram
  • Identify critical chain tasks
  • Reflect project progress through weekly reporting demonstrating adherence to schedule
  • Excellent documentation and technical writing skills.
  • Ability to perform root cause analysis using common tool sets (IS/IS NOT, Fishbone, etc)
  • Comfortable in a fast paced, evolving and still somewhat entrepreneurial organization.