San Jose Metro Area, CA
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
- Monitors and facilitates work associated with Quality projects across cross functional teams including development, operations, quality, regulatory, facilities, and provides direction and guidance to 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.
- Knowledge of quality systems and medical device/ in-vitro diagnostics regulations.
- Problem solving skills and 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.
- BS/BA in science, engineering or business administration OR equivalent combination of education and work experience.
- Project Management specific training and/or certification preferred.
- Master s degree preferred.
- 5-8 years project management, quality management and/or relevant experience.