MicroVention, Inc

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Sr Project Manager, Post Market Quality (Medical Device)

at MicroVention, Inc

Posted: 9/22/2019
Job Reference #: 453574
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Job Description

Title
Sr Project Manager Post Market Quality (Medical Device)

Job Description
Manages post-market quality projects including post-market surveillance deliverables. Job duties:
  • Proactively drive planning and execution of the post market quality strategy through the effective use of Project Management best practices and integration of Quality System Requirements into project team activities. Projects include but are not limited to leading the development of a database in partnership with several cross functions, and implementation of standard work in partnership with external stakeholders in order to increase efficiency.
  • Lead post market surveillance deliverables for all products related to EU MDR and other regulations as necessary in close partnership with cross functions including Regulatory Affairs, Risk Management and Medical Affairs.
  • Perform all aspects of project management, including but not limited to:
    • Establish and manage project charter.
    • Define project plan with input from the team and maintain the plan.
    • Manage project cross functional resources including but not limited to Developers, Analysts, Scientists, Regulatory Affairs and Clinical Research subject matter experts, Clinicians and Engineers.
    • Strong communication skills including the ability to establish communication plan and execution of the plan.
    • Lead contact for all cross functional internal stakeholders regarding project activities and establish and maintain relationships with all global internal and external stakeholders.
  • Perform additional duties as assigned.


Auto req ID
7807BR

Location
Aliso Viejo, California, USA

Department Name
525-Field Assurance

Qualifications
  1. Bachelor’s Degree in related field or equivalent work experience.
  2. Minimum 6 years of project management experience in the medical device industry including implementation of corporate programs.
Desired Qualifications
  1. Demonstrated knowledge of project management practices, including use of different tools and techniques.
  2. Strong proficiency in the understanding and practices of quality principles and regulatory requirement understanding.
  3. Knowledge and experience with some aspects of data mining and analytics.
  4. Proven work history of complex projects and systems where analysis of the current state requires an in-depth evaluation.
  5. Ability to play a significant role in developing and accomplishing department and team goals, and proactively seek to establish best practices with a bias toward actions and results.
  6. Ability to self-start and work independently to actively drive multiple projects to completion.
  7. Strong interpersonal skills to build effective relationships with external and internal business partners and proven ability to work effectively and collaboratively in a team environment.
  8. Proficiency in standard computer programs including MS Office.
  9. Solid knowledge of Excel is a plus.


External-Facing Title
Sr Project Manager, Post Market Quality (Medical Device)

Posting Country
US - United States