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Quality & Regulatory Strategy Program Manager

Req ID:  2603

Working Location: Nationwide 

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 requrements, 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.

 

* 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.

 

* 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.

Job Requirements

REQUIRED QUALIFICATIONS: 

 

* 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; PMP certification preferred.

 

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.

 

* Strong leadership skills and the ability to operate effectively in a team environment.

 

* 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.

 

* 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. 

 

· Knowledge of the software development life cycle (SDLC) and deliverables.

 

· Experience in working within or with Japanese companies is desirable.

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.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

Olympus…True To You. True To Society. True To LIFE.

 

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || 


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