Olympus America Inc. Program Manager, RA/QA Strategy in Brooklyn Park, Minnesota
As a Program Manager working on the RA/QA team, you will be empowered and inspired to do your best work. You will contribute to our mission by leading innovation, driving continuously improvement and executing strategic projects that impacts the entire organization. A typical day for you will include:
*Manage all aspects of a project and drive execution to schedule.
*Meet with cross-functional project team members to drive deliverable completion or remediate issues to maintain project schedule.
Planning and executing 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.
Building team ownership and commitment to project and business plans and defines project milestones and resource requirements.
Conducting routine meetings to ensure accountability and milestone achievements with team(s).
Setting prioritization of team member activities and follow up on actions.
Actively seeking collaboration and builds relationships with internal customers and external partners to improve overall outcomes and timely project completion.
Collaborating with business users, internal technology teams across Olympus and vendors to establish and prioritize business and technology requirements.
Managing and serving 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.
Analyzing 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 identifying and assessing 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.
Providing regular project updates (written and verbal) to appropriate management and Olympus governing boards.
Serving on PMO and project steering committees.
Managing cross-functional project teams providing direction and guidance as well as coaching and mentoring as needed; providing input to functional directors/managers on team member performance.
Owning of project planning and management responsibilities for all assigned projects. Includes development of a project charter, project plan, schedule, etc.
Developing and managing budgets for the project including resource loading, external expenses and capital requirements.
Developing a team culture of continuous improvement and teamwork that strives to improve in quality, safety, delivery and cost.
Bachelor's 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.
* Ability to travel up to 40% of the time, domestically or internationally.
- Availability to take evening and early morning teleconferences.
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.
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.
Ability to respond well under pressure and manages stress.
Effective at dealing with change and ambiguity as business needs shift, demonstrating flexibility while ensuring compliance.
Ability to gain 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 proficiency in Excel, Power Point, Visio, and Word.
Knowledge of design control and verification/validation.
Knowledge of the software development life cycle (SDLC) and deliverables.
Experience in working within or with Japanese companies.
We realize work isn’t just a job to you.
It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.
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. We’re currently looking for a Program Manager, RA/QA Strategy to join us in our Brooklyn Park, MN office.
Let’s inspire healthier lives, together.
The Program Manager, RA/QA Strategy will 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). The incumbent will be 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.
At Olympus, we put a lot of good back into the world, and what we do really matters. We are committed to making people’s lives healthier, safer and more fulfilling every day by crafting innovative optical and digital solutions in medical technologies, microscopy, industrial solutions, cameras, and audio recorders.
We view our relationship with and commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our vision, and everyone here helps to make it a reality. We’re invested in our employees, great ideas, and how they impact the communities around us. We see the world through multiple lenses and come together to find the right answers; the best solutions.
TRUE TO YOU. TRUE TO SOCIETY. TRUE TO LIFE.
Olympus Surgical Technology America
Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled
Olympus Surgical Technology America at http://www.olympus-osta.com/
Program Manager, RA/QA Strategy
Minnesota, Brooklyn Park
Brooklyn Park GYR ACMI Inc
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Olympus is an Equal Opportunity Employer, and our policies prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.