Project Manager PMO QA

Job Description

Plan and manage the execution of complex quality and regulatory projects across the Americas or globally relating to integration, process standardization or improvement, and IT system infrastructure tools supporting the Complaint Center of Excellence. Responsible to directly, and indirectly lead cross-functional teams in the execution of end-to-end programs and project plans. This will include business case evaluation, budget analysis, resource requirements, detailed timelines, and risk assessments at the project level.  

Job Duties

• Plans and executes quality and regulatory key large-scale infrastructure and system integration initiatives that support the Complaint Center of Excellence for Olympus globally.
• Build team ownership and commitment to project and business plans and defines project milestones and resource requirements. Conduct routine meetings to ensure accountability and milestone achievements with team(s). Sets prioritization of team member activities and follow up on actions.
• Actively seeks collaboration and builds relationships with internal customers and external partners to improve overall outcomes and timely project completion.
• Collaborates with business users, internal technology teams across Olympus and vendors to establish and prioritize business and technology requirements.
• Manages and serves as the subject matter expert on project teams toward understanding customer requirements, regulatory requirements and technical capabilities of a process or system tool to be deployed.
• Analyses the feasibility of, and develops requirements for, business processes focusing on the effective use of resources or new systems and enhancements to existing systems from a business and technology perspective to ensure the design or change fits the needs of Olympus.
• Proactively identify and assess areas of risk, escalate issues in a timely manner and proactively propose solutions.  Implement and manage project changes and interventions to achieve timely project outputs.
• Provide regular project updates (written and verbal) to appropriate management and Olympus governing boards. Serves on PMO and project steering committees.
• Manages cross-functional project teams providing direction and guidance as well as coaching and mentoring as needed; provides input to functional directors/managers on team member performance.
• Owner of project planning and management responsibilities for all assigned projects. Includes development of a project charter, project plan, schedule, etc.
• Develops and manages budgets for the project including resource loading, external expenses and capital requirements.
• Develop a team culture of continuous improvement and teamwork that strives to improve in quality, safety, delivery and cost.
• Other essential duties as directed.

Job Qualifications

Required:

• BS degree in engineering or technical Discipline.
• Minimum of 8 years of experience in the medical device field or any other regulatory controlled industry.
• Minimum of 5 years of related experience analyzing, clarifying and translating business requirements into functional and technical specifications.
• Working knowledge of applicable FDA QSR, ISO 13485 regulations and applicable industry standards
• Knowledge of the software development life cycle (SDLC) and deliverables
• Travel up to 20% of the time domestically or internationally, availability to take evening and early morning teleconferences

Preferred:

• Proven planning and organizational skills with background and experience on project management principles, practices, techniques, and tools
• Strong leadership skills and the ability to operate effectively in a team environment. Group facilitation, mediation, and conflict resolution skills.
• Ability to analyze complex problems, interpret operational needs, and develop integrated, creative solutions.
• Must be able to work independently, self-motivated, a sense of ownership with a strong sense of urgency to drive for results.
• Responds well under pressure and manages stress. Effective at dealing with change and ambiguity as business needs shift, demonstrating flexibility while ensuring compliance.
• Ability to gains cooperation and commitment from people through influence, not authority.
• Excellent verbal and written communication skills and comfortable presenting to small and large groups
• Expert level of Microsoft Project and proficient in Excel, Power Point, Visio, and Word
• Knowledge of design control and verification/validation is preferred. 
• Experience in working within or with Japanese companies is desirable.