Engineer, Principal Quality Assurance

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

Develop, maintain, and support the company Quality System, regulatory requirements and business strategy. Continuously improve Quality performance related to New Product Development, procurement, manufacturing, and metrics related to the strength of the site Quality System. Leads complex projects. Mentors less experienced engineers within and across OSTA sites in best practices for the use of Quality tools and methods. Expected to serve as a backup to the Management Representative for the location.

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

• Leads and participates in Cross-Functional Teams to support new product development, procurement, manufacturing representing Quality Engineering discipline.
• Completes assigned Quality Engineering tasks to schedule.
• Leads promotion of Quality and Regulatory requirements.
• Leads or participates in the development of process and procedure development/changes.
• Provides resident expertise in the application of Quality Sciences including statistics, data analysis, problem solving, and the creation of system solutions.
• Develops new approaches to solve problems identified as part of the team.
• Assists others to lead and develop novel approaches within the 5E teams.
• Leads the implementation. compliance, and maintenance of standards (e.g., FDA, ISO13485) and OGA Quality policies and procedures for the site.
• Trains location personnel on all aspects of the Quality System and regulatory standards.
• Serves as a mentor and advisor for the Quality team to assist in developing Quality Engineering skills and capabilities.
• Applies the requirements of the Quality System to processes, products or services for the location.
• Leads, supports, and guides the manufacturing line to address quality issues and resolution using the best Quality techniques and principles .
• Develops and maintains the validation and verification strategy for new and existing products and processes.
• Leads the development and maintenance of Master Validation Plans.
• Participates in the CAPA process as required as an assignee or project team member.
• Monitors product and process performance metrics and acts upon trends with minimal guidance.
• Authors, collaborates, and approves Quality System documentation including change orders, DHF, DMR, DHR, labels and labelling, etc.
• Conducts internal, vendor, and process audits to schedule.
• lnterface with suppliers to resolve Quality issues.
• Develops and drives measurable Quality improvements relating to products, processes and services.
• All other essential related duties as required