Process and System Governance Manager
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 Process and System Governance Manager to join us in our Bartlett, TN office.
Let’s inspire healthier lives, together.
The Process and System Governance Manager manages the alignment of the global complaint handling process across Olympus globally with focus on the business process, system tools and master data that supports the efficient and accurate handling of product complaints in all markets. The Process and System Governance Manager monitors the complaint system health and performance to take immediate action to address excursions from targets or norms. He/She produces data as input into legal manufacturers Quality Systems.
In a typical day, you will:
* Leads and manages CoE team members.
* Manages the development and performance of staff.
* Ability to assess and develop team talent to support business objects and personal objects of employees.
* Prioritize resources based on the tactical objectives of the organization.
* Establish and manage a formal Complaint Handling Governance program to support key global complaint handling operations.
* Develop, communicate and maintain process and system Governance policies, standards, and guidelines which are aligned with
Olympus culture and in accordance with applicable laws and regulations.
* Ensures alignment with the overall strategy of the organization.
* Approves the system tool requirements, policies, guidelines and KPIs.
* Manage all OGBR-Ms changes that deal with Complaint Handling.
* Ensures alignment across all Olympus business centers complaint and risk processes and sub-processes.
* Manages the proper alignment and coordination of all complaint process and system improvements across Olympus globally.
* Sets priorities for process and system tool improvement projects. Ensures all technology, application, and data changes are
aligned across Olympus for complaint handling.
* Coordinates change management for process and system tool changes.
* Provides high-level direction of EtQ System and Data Governance with business partners.
* Partners with Olympus IT, consultants, service & repair, Market Quality and Quality Systems across Olympus to manage system tool change.
* Monitors and performs master data management changes and coding updates for legal manufacturers.
* Manages RSS file maintenance process, including cascade of new codes/flat files to service systems across Olympus.
* Monitors complaint handling process performance data for trending, including monthly data pulls/calculations that feed to legal
manufacturers Quality Systems.
* Lead or support special quality and compliance projects as requested, and perform other assigned duties, as needed.
* Perform other duties as assigned.
* A minimum of a 4-year college degree (Bachelor’s Degree) or equivalent in a technical or science-related field is required.
* Minimum 5 years Regulated Quality Experience, Medical Device Experience (working knowledge of applicable FDA QSR, ISO 13485 regulations and applicable industry standards).
* Minimum 5 years of related experience analyzing, clarifying and translating business requirements into functional and technical specifications.
* Minimum 3 years of people and project management experience.
* Strong project management skills; strong computer skills and use of software applications such as MS Windows, MS Office (Word, Excel, PowerPoint); strong written and oral communication skills, are required.
* Approximately 25% travel, including globally.
* Availability to take evening and early morning teleconferences.
* Master’s Degree or equivalent is preferred, with preferred areas of study being in the Scientific or Engineering discipline.
* Minimum 3 years of professional experience in computer system validation and testing in pharma or medical device company preferred.
* Ability to influence outside of direct control at Sr. and Internationally.
* Group facilitation, mediation, and conflict resolution skills.
* Six Sigma Black Belt Certification preferred.
* Comprehensive understanding of principles and concepts of Process Excellence, Statistical Process Control and Applied Statistics
* Proven planning and organizational skills with background and experience on project management principles, practices, techniques and tools.
* Ability to handle multiple projects simultaneously and to discern major quality issues
* 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
* Proven analytic and problem-solving skills.
* Global communication capabilities.
* Knowledge of the software development life cycle (SDLC) and deliverables.
* Experience in working within or with Japanese companies is desirable.
* EtQ, Oracle, SAP and enterprise system experience preferred.
* Must have excellent influencing skills, communication skills, presentation skills, listening skills, interpersonal skills, negotiating skills, coaching and feedback skills, and team oriented.
* Must have proven leadership skills in associate involvement and teamwork.
* Must have the ability to work under pressure achieving consistently high results in quality, efficiency, and compliance through individual and team efforts.
* Must have the ability to analyse complex data and integrate multi-disciplinary feedback.
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.
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Olympus Surgical Technology America
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
Job Type: Full-time
- People and Project Management: 3 years (Required)
- Regulated Quality with Medical Devices: 5 years (Required)
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off
- Parental leave
- Professional development assistance
- Tuition reimbursement