Quality Systems SME - Quality Integration PM at Softworld Inc

Job Title: Quality Systems SME - Quality Integration Project Manager

Location: Santa Rosa CA (Hybrid Role,2-3 Days onsite)

Onsite Requirements:

• Solid understanding of ICH 13485 standards
• Experience leading Quality System Integration
• Global, Medical Device experience

Job Description:
Role profile:

• Responsible for leading cross functional activities in the achievement of project objectives through management of Quality & Compliance activities.
• Develops project scope and objectives. Establishes and tracks critical milestones, timelines, and contingency plans.
• Follows up throughout project process to ensure project goals are achieved. Collaborates with personnel to ensure effective management of project deliverables.
• Gathers data to formulate project plan and objectives. Manages project team activities during project implementation.
• Directs communication of project status, milestones, timelines, and budget to management.

Main responsibilities include:

• Issue and Risk escalation, of impactful issues within the project elements.
• Develop project / program budgets and updates based on sound rationales and track routinely.
• Create Capital Asset Requests (CAR) where appropriate.
• Define impact to the business, attaining buy in from stakeholders/ customers.
• Communicate effectively within the team and externally.
• Present project status, plans, issues, and recommendations to senior management.
• Support or conduct project, technical and financial reviews.
• Facilitate decision making through the development of robust proposals.
• Negotiate and implement plans, deliverables and priorities with key internal and external stakeholders.
• Apply standard project management applications/tools and processes.
• Prioritize and track the aspects of several projects including the integrated project plans, budgets, and resources.
• Utilize Process Excellence to ensure successful delivery of objectives and tasks.
• Identify interdependencies and ensure connections between project elements.
• Lead and serve as the primary contact for cross-functional project teams, external alliances and senior management.

Essential skills criteria:

• Significant understanding of ICH 13485 guidelines
• Significant understanding of 21 CFR 820 compliance
• Experience leading Quality System Integration
• Significant experience managing resources within a global organization, preferably in a medical devices and diagnostics environment.

Proven success in:

• CAPA / Investigations & Deviations
• Developing functional strategic plans in alignment with the corporate strategic goals
• Leading and developing high performing cross functional & matrix teams.
• Building interdependent partnerships to optimize value proposition with limited authority.
• Outstanding communication skills which enable strong collaboration and partnering both internally and externally
• Ability to successfully lead without authority in ambiguous and complex environment.
• Big picture orientation with attention to detail, complemented by a "hands-on" operational and business planning orientation.

Desirable skills criteria:

• Demonstrated experience leading strategically significant projects.
• Multi-functional experience, including Project Management, RA, QA, R&D, Operations and Customer Services, FDA regulatory experience and statistical analysis.
• Process excellence/six sigma/design excellence experience and certifications highly desirable.
• PMP / ASQ / CQA Certification
• Experience document control for Cardiovascular and/or Orthopaedic devices.
• Experience tracking documentation with Track Wise and/or Veeva Vault