Contract, Quality Engineer I

at  Olympus Corporation of the Americas

Workplace Flexibility: Onsite
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 Quality Assurance Engineer I is responsible for providing Quality Engineering input to support Production, Operations and Engineering activities. Maintains and follows Quality Engineering methodologies, systems, and practices which meet Olympus, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on Quality initiatives to support departmental, functional, site, divisional and corporate Quality goals and priorities. When needed, works with Olympus Tokyo representatives/liaisons to resolve Quality related issues.

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.
Olympus Canada Inc. (OCI)—a subsidiary of Olympus Corporation of the Americas—manages the Company’s operations and workforce throughout Canada in roles such as sales, marketing, service, and support functions. Based in Richmond Hill, ON, OCI is committed to developing our employees and supporting our local communities. For more information, visit olympuscanada.com and truetolife.com.
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

• Provide Quality Engineering support on projects to implement new product introduction or alternate repair activities.
• Train Technicians, Supervisors and other employees on the use of new products or processes.
• Perform packaging and equipment validations and other verifications/validations to support new product or new repair introductions.
• Provide technical guidance to the Change Control Board; educate members on technical issues associated with assigned projects.
• Support continuous improvement measures by providing technical information and reviewing processes as they are revised.
• Address or initiate Engineering Change Orders (COs) in a timely manner to maintain project schedules and/or achieve acceptable levels of compliance. ·
• Supports problem solving activities to resolve Quality issues.
• Support and/or drive corrections and corrective actions to resolve non-conformances (DMNs, NCRs, CAPAs and ADT) with minimal guidance.
• Communicate significant issues or developments identified during Quality assurance activities and support process improvements identified by cross-functional teams (CFTs) and management. ·
• Analyze Production and Complaint data and identify any significant trends.
• Support the Quality Management System (QMS) by performing periodic product, process, and internal audits.
• Support and participate in external audits as needed.
• Work with Operations to resolve material issues.
• Work directly with the OEM to resolve Quality problems identified through complaint investigations and/or other sources of Quality data.
• Perform all other related duties as assigned.