Project Manager III
Our Client is looking for a Project Manager III to join their team. This person will support projects for the Supplier Quality team.This person will be leading projects, facilitating meetings, acting as a team member of projects. The Project Manager 3 will perform actions required to successfully complete projects on time. Projects must ensure maintained compliance to applicable regulatory standards. Examples of project types may include continuous improvement projects, quality management system projects, product improvement projects and Corrective Action and Preventive Action (CAPA) implementation projects.
Essential Duties and Responsibilities:
- Develop and maintain project timelines and provide updates and feedback to leadership.
- Create, refine, and publish process documentation within a regulated quality system.
- Exercise judgment within defined procedures and policies to determine appropriate action.
- Manage project definition and scope with the stakeholders including project core team, sponsors and leadership.
- Drive the project team and maintain accountability for action items. coordinate activities/tasks and resources across all departments including but not limited to, Clinical Affairs, Marketing, Technical team, Quality, Regulatory Affairs, and Operations within the boundaries of an indirect reporting structure.
- Coordinate key stakeholder communications and meetings to review project status, risks, strategy and implementation, as appropriate.
- Drive project progress by leading through influence and operate as an individual contributor as needed.
- Be flexible and able to adapt while collaborating with internal and external individuals at all levels and backgrounds.
- This position assumes and performs other duties and assignments as required by department.
- Exercises good judgement in selecting methods and techniques for obtaining solutions.
- Normally received little instructions on day-to-day work, general instructions on new assignments.
- Ability to organize, collate and categorize information.
- Detail oriented with strong time management skills.
- Extremely strong proficiency in Microsoft Office, Microsoft Project, and Microsoft Excel is required.
- Excellent communication skills with the ability to convey technical and business information clearly and effectively through informal and formal documents, reports, and presentations to senior management.
- Demonstrated successful management of a complex project.
- Proven ability to work hands-on in a fast-paced environment.
- Experienced team management skills including interpersonal, teamwork, and management skills.
- Experienced in project risk management, mitigation of project risks and balancing of project constraints.
- Expert experienced understanding of project management techniques, and tools.
- Advanced knowledge of the product development process and phase gate Design Control process is required. Advanced knowledge of GMP's and ISO standards.
- Possesses intermediate understanding of the product development process and medical device design control requirements. Working knowledge of GMP's and ISO standards.
- Experience creating and/or conveying engineering or process requirements and ensuring requirements are met by project deliverables.
- Understand Technical concepts related to supplier quality Engineering Functions such as Validation, Cpk, and supplier evaluations.
Education / Experience Requirements:
- Familiar with Confluence, OneNote, SharePoint, Agile, and Oracle.
- Program Management certification, i.e. PMP or equivalent, is preferred.
- Experience working in medical device industry compliance to ISO 13485 and FDA or other related regulated industry.
- Requires a Bachelors or higher in a technical discipline.
- Minimum of 5-8 years of related experience.
- A Master's degree or equivalent may substitute 2 years of experience.
- A PhD may substitute for 3 years of experience.