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Olympus Corporation of the Americas Senior Manager, Global Quality Management System in Westborough, Massachusetts

Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; ONTARIO, RICHMOND HILL; PENNSYLVANIA, CENTER VALLEY

Workplace Flexibility: Field

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Senior Manager, Global Quality Management System is responsible for the global Quality Management Review. In this role, you will plan, coordinate, prepare and execute the global Quality Management Review at scheduled intervals and additional reviews as required. This will include following up on the management review to close identified actions and lead continuous improvement and completing all reports.

This role will partner close with other Quality and cross-functional leaders at site and global levels to assess the impact of changes to the Quality Management System and enable a timely completion of inputs to the Quality Management Review.

Job Duties

  • Oversee the management of the Quality Management Review lifecycle including:

  • Plans the global Quality Management Review schedule and aligning with site/QMS level reviews.

  • Coordinates content for Quality Management Review across site and global level including data from site level reviews.

  • Prepares content for each Quality Management Review.

  • Initiates and/or hosts a review of data prior to scheduled meetings.

  • Completes reports as an output of Quality Management Review.

  • Follow-up and tracking of outputs and actions for completion.

  • Fosters a culture of continuous improvement by identifying areas to improve, driving continuous improvement initiatives, and utilizing problem solving methodologies.

  • Develops and fosters working relationships with colleagues globally to drive standardization, collaboration, and support growth across Olympus.

  • Ensures functional groups adhere to the company’s Management Review procedures.

  • Effective Subject Matter Expert role for Management Review and tools in scope.

  • Establishes metrics to evaluate QMR performance.

  • Communicates with each site to promote and select escalated data for the global Quality Management Review.

  • Participates in Quality initiatives as a cross functional contributor.

  • Demonstrates operational excellence and ensures quality in all deliverables.

  • Supports CAPA investigations & audit requests (internal & external).

  • Supports audits as a Subject Matter Expert for Management Review, as required.

  • All other duties as assigned

Job Qualifications

Required:

  • BS Degree in science or demonstrated equivalent professional experience.

  • Minimum of 10 years Quality Management System experience required with demonstrated experience improving and/or maintaining quality management system (medical device is preferred) and preparing Quality Management Reviews.

  • Minimum of 5 years of experience required in data analysis, trending and presenting data in a manner to drive informed decision making.

  • Excellent understanding and working knowledge of appropriate global regulations, requirements and standards such as ISO 13485:2016, ISO 9001:2015 and FDA Quality System Regulation.

  • Excellent working knowledge of Quality Management Review.

  • Travel to other company (regional) facilities may be required, up to 10%.

  • Travel to other facilities/locations may be required, up to 10%

Preferred:

  • Strong attention to detail.

  • Ability to operate efficiently, proactively and effectively in a fast-paced environment.

  • Strong verbal and written communication skills, with the ability to interact with all levels of the organization.

  • Strong stakeholder management and ability to influence and coach others.

  • Ability to participate as a functional leader of a self-directed work organization and utilize the resources of the team.

  • Having the global viewpoint to establish and maintain the QMS compiled with global requirements.

#LI-Remote

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

  • Competitive salaries, annual bonus and 401(k)* with company match

  • Comprehensive Medical, Dental, Visions coverage effective on start date

  • 24/7 Employee Assistance Program

  • Free virtual live and on-demand wellness classes

  • Work-life balance supportive culture with hybrid and remote roles

  • 12 Paid Holidays

  • Educational Assistance

  • Parental Leave and Adoption Assistance

  • Volunteering and charitable donation match programs

  • Diversity & Inclusion Programs including Colleague Affinity Networks

  • On-Site Child Daycare, Café, Fitness Center**

*US Only

**Limited locations

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks .

About us:

Our 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 costs, and enhance the quality of life for patients and their safety.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

Let’s realize your potential, together.

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) || Massachusetts (US-MA) || Westborough ||

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