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
- 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.
- 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.