Quality Management System Project Manager (Contract, Santa Clara, CA)

Description:

I’m looking for a #Project_Manager for a medical device company in Santa Clara, CA. This role will be providing technical quality and compliance project leadership to various programs associated with quality management systems (QMS).  It is a 6 to 36 months contract on W2. Pay Rate $45/hr

Please email your resume attached as a Word Doc along with your desired Hourly Rate, your current location, visa status and date you are available to start a new position. Please make certain your resume clearly details your experience with the skills required for this requirement.

Also please provide a brief writeup about why you are a match for the position that can be passed along to the manager. If you have worked at Roche or Genentech in the past please provide your previous managers' name, so they too can be passed along to the hiring manager.

Job Summary
 
Responsible for all aspects of various quality systems projects of a moderately complex nature. Provides technical quality and compliance project leadership to various programs associated with quality management systems (QMS), continuous improvement, QMS implementation. Interfaces with all areas affected or supporting the project. Develops and directs detailed work plans, schedules, project estimates, spending, resource plans, and status reports. Conducts project meetings and is responsible for project tracking and analysis. Monitors projects from initiation through delivery including monitoring budget/spending

Essential Responsibilities

  • Monitors and facilitates work associated with Quality projects across cross-functional teams including development, operations, quality, regulatory, facilities, and provides direction and guidance to the core and extended team members to achieve project goals.
  • Ensures that program objectives are determined, met and communicated with management and relevant stakeholders (including but not limited to project team, governance bodies), integration of multiple functions is facilitated, logistics are effectively coordinated, and budgets are adhered to.
  • Accountable for quality implementation on projects in the following areas:

 

  • Risk management
  • Critical path and Scenario analysis
  • Robust planning

 

  • Ability to identify and communicate issues proactively to a wide range of stakeholders.
  • Creates, coordinates and maintains integrated project plans using project management tools.
  • Identifies gaps, potential bottlenecks or delays, challenges assumptions and proposes options to close gaps and get projects back on schedule.
  • Guides and manages preparation for project milestone reviews.
  • Manages meetings to include setting agendas, organizing meeting time and meeting minutes.
  • Consistently executes project management processes, and may lead improvement initiatives.
  • Follows best practices in project teams and fosters continuous improvement by sharing knowledge via continuous exchange.
  • Performs other duties as assigned.


Skills              
 

  • 5-8 years of project management, quality management and/or relevant experience.
  • Knowledge of quality systems and medical device/ in-vitro diagnostics regulations.
  • Problem-solving skills and the ability to coordinate project-related activities.
  • Strong written and oral communication skills.
  • Basic stakeholder management and facilitation skills.
  • Proficient in MS Project and/or other Project Management Tool.
  • Ability to manage projects with ambitious milestones.
  • Ability to escalate and drive management decisions in relation to project execution and resource needs.


    
Education
 

  • BS/BA in science, engineering or business administration OR an equivalent combination of education and work experience.
  • Project Management specific training and/or certification preferred.
  • Master’s degree preferred.

Skills:

quality management, quality system regulation, quality systems, quality system, quality system specialist, quality systems engineer, quality systems manager, qms, quality systems management, quality system regulations
Please review all application instructions before applying.

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