Quality System Engineer, Principal

at  Olympus Corporation of the Americas

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

JOB DESCRIPTION

To develop, maintain and continuously improve the Quality System across the Americas by driving industry best practices, procedural harmonization and seamless quality system integration.
Act as an ambassador of global quality harmonization to share, develop, deploy and integrate strategic plans and practices across Olympus globally. To interface with functional business partners within the quality system to ensure that development and implementation of the quality system meets business needs as well as enables innovation and flexibility in the business.

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.

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 DUTIES

• Ensure that a Quality System is established, implemented, and maintained to the highest levels of accordance with US and Internation requirements.
• Review and approve release of changes to QMS documentation and assess impact to QMS certification, addressing any substantial changes with the Notified Body.
• Ensure Intercompany Quality Agreements are established and maintained.
• Manage Notified Body communication and relationship.
• Support and participate in internal and external Quality Audits (including health authorities and notified bodies) an ensure related corrective action activities are completed in a robust and timely manner.
• Support the CAPA process.
• Show strong ability to influence without direct authority across functional groups, regions and leadership.
• Provides resident expertise in the application of Quality sciences including data analysis, problem solving and the creation of system solution for Quality System issues.
• Will act as an expert resource in applicable standards and local QMS requirement knowledge for cross functional teams.
• Lead/support significant Quality System projects effectively using a working knowledge of project management techniques.
• Develop innovative and practical solution to complex and unique process problems and system improvement through the use of best practices
• All Other Essential Duties as directed.