RA/QA Strategy Program Manager at Olympus Corporation of the Americas in Westborough, MA
Are you looking for a company that cares about people's lives and health, including yours? At Olympus, we help make people's lives healthier, safer and more fulfilling, every day. Let's inspire healthier lives, together. 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 QMS (Quality Management System). 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 QMS (Quality Management System) of Olympus in the Americas or globally. Build team ownership and commitment to project and business plans and defines project milestones and resource requirements. 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 Requirements REQUIRED QUALIFICATIONS BS degree in engineering or technical Discipline. Minimum of 5 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. Minimum of 2 years of program management experience. OTHER CONSIDERATIONS (travel/hours availability etc.):
Travel up to 40% of the time domestically or internationally availability to take evening and early morning teleconferences. PREFERRED QUALIFICATIONS Working knowledge of applicable FDA QSR ISO 13485 regulations and applicable industry standards. Proven planning and organizational skills with background and experience on project management principles practices techniques and tools. Group facilitation mediation and conflict resolution skills. Ability to analyse 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. Effective at dealing with change and ambiguity as business needs shift demonstrating flexibility while ensuring compliance. 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. Knowledge of the software development life cycle (SDLC) and deliverables. Experience in working within or with Japanese companies is desirable.
Salary Range:
$80K -- $100K
Minimum Qualification
Program Management, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
Travel up to 40% of the time domestically or internationally availability to take evening and early morning teleconferences. PREFERRED QUALIFICATIONS Working knowledge of applicable FDA QSR ISO 13485 regulations and applicable industry standards. Proven planning and organizational skills with background and experience on project management principles practices techniques and tools. Group facilitation mediation and conflict resolution skills. Ability to analyse 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. Effective at dealing with change and ambiguity as business needs shift demonstrating flexibility while ensuring compliance. 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. Knowledge of the software development life cycle (SDLC) and deliverables. Experience in working within or with Japanese companies is desirable.
Salary Range:
$80K -- $100K
Minimum Qualification
Program Management, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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