The Quality Project Manager works primarily on projects within the Quality Assurance department, helping to identify areas of improvement, collect requirements, write and revise project plans, determine validation strategies, lead cross-functional projects stemming from audit non-conformances and Quality Objectives. Owns projects from initiation through implementation.
Responsibilities include defining and controlling project scope, facilitating formal project changes, managing product and project risk, developing timelines, and coordinating qualification and validation activities.
- Perform all work in compliance with company quality procedures and standards.
- Performs other duties as assigned.
- Develop project plans, risk assessments, specifications, validation plans, protocols, and reports that support the qualification and validation of impacted processes.
- Develop and maintain accurate timelines using a risk-based approach for multiple projects
- Manage multi-phased, multi-year projects that impact the Quality System, and various work centers, etc.
- Represent and advocate for Quality Assurance throughout the project’s lifecycle.
- Promote Quality System Regulation and regulatory compliance into assigned projects.
- Write and own the implementation plan of new and improved manufacturing processes.
- Makes detailed observations, analyze data, and interprets results.
- Investigate, create, and develop new methods and technologies for project advancement.
- May participate in scientific conferences and contribute to scientific journals.
- Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
Studies and Experience:
- Minimum of Bachelor’s degree in related field.
- Formal PMI (Project Management Institute) project management certification (PMP, CAPM) is preferred.
- Knowledge of ISO 9001, 13485, 21 CFR 11, MDSAP, IVDD/IVDR preferred but not required
- 1-2 years of project management is required.
- 3 plus years in project management is desired.
Skills and Qualifications:
- Knowledge of validation strategies as they pertain to the medical device manufacturing industry.
- Ability to relate with people at all levels within an organization.
- Ability to manage highly cross-functional projects, including stakeholders internal and external to Manufacturing
- Must work well independently as well as in a team environment.
- Must be an effective communicator
- Ability to negotiate effectively with many different stakeholders and facilitate effective solutions
- Must be able to work on multiple projects simultaneously.
Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.