Senior Global Quality System Engineer

Working Location: MINNESOTA, BROOKLYN PARK; MASSACHUSETTS, WESTBOROUGH; 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 Global Quality Systems Engineer is responsible for the oversight and monitoring of Global Quality Management System deployments across Olympus. 

 

This role will partner closely with Global Process Owners and Quality Leads to lead and guide the deployment approach, communication of the deployment strategy and monitoring of performance across multiple sites. 

Job Duties

• Work with Global Process Owners (GPOs) to define deployment and implementation strategies for releasing Global Quality Management System documents
• Develops process improvements as applicable to improve efficiency and monitoring
• Coordinates the implementation or deployment activities of all global processes across the impacted sites
• Communicates with Quality sites the status of deployment activities
• Develops and implements a mechanism to monitor deployment activities
• Active participation in the Document Control Community of Practice
• Works closely with document control, GPOs and Quality leads
• Demonstrate operational excellence and ensure quality in all deliverables
• Supports CAPA investigations & audit requests (internal & external)
• Support audits as a Subject Matter Expert for Global Quality System deployments, as required.
• All other duties as assigned.

Job Qualifications

Required:

• BS Degree required or demonstrated equivalent professional experience.
• Minimum of 5 years Quality Management System experience improving and/or maintaining quality management system (medical device is preferred).
• 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 Systems, including notified bodies, certifications and external audits.
• Travel to other company (regional) facilities may be required, up to 10%
• Travel to other facilities/locations may be required, up to 10%

 

Preferred:

• Working within a Global Quality Management System, supporting multiple sites and stakeholders is 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.
• Experience with PowerBi is an asset
• 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