Senior Quality Engineer

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

The Product Quality Engineer is responsible for the design, development and management of projects for legacy products. The Product Quality Engineer provides organizational support with a focus on Design Quality activities. Works with internal/external manufacturers providing finished products, services, components, and sub-assemblies to ensure compliance with company policies and procedures and medical device regulations. The Product Quality Engineer will partner with Operations, R&D, Supply Chain and other departments to continuously improve products and processes that meet all internal and external requirements and regulations.

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

• Drive the design & execution of Production Release Process project for components & finished devices.
• Lead and implement complex projects including quality improvement initiatives.
• Sets direction for cross-functional teams and drives towards compliant and efficient solutions to complex problems.
• Lead Process/Design Risk Analysis.
• Provide leadership in understanding of the quality regulations to other disciplines.
• Lead multiple product Design Control activities for new product development efforts.
• Support Process/Design Validation/Verification activities and approach including software validation.
• Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting.
• Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing.
• Know and follow all laws and policies that apply to one’s job, and maintain the highest levels of professionalism, ethics and compliance at all times.