Senior Global Field Corrective Action Manager

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 Senior Global FCA Project Manager is a leader responsible for overseeing all aspects of Field Corrective Actions (FCAs), from initiation to successful completion. You will spearhead cross-functional teams in crafting comprehensive global plans and documentation to mitigate risks, adhere to regulatory requirements, and address regional customer needs – all delivered in a timely and compliant manner.
This critical role demands a strong blend of analytical thinking, problem-solving, and exceptional communication skills to mitigate complex quality issues. You will effectively engage with stakeholders at every level, from executives and managers to engineers, field personnel, and regulatory agencies, to foster alignment on recall strategies, and smooth execution.

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

• Lead global FCA teams’ planning and preparation activities to implement FCA decisions determined by the FCA Review Board.
• Collaborates with team members to develop a detailed global FCA plan, including timeline, milestones, resources, and activities.
• Monitor the progress of FCA preparation, and execution activities, identifying and resolving any issues or roadblocks promptly to meet deadlines and compliance and quality requirements.
• Ensure project deliverables are completed through alignment and effective stakeholder collaboration.
• Collaborate with cross-functional representatives to draft quality customer notification letters, safety advisories, or field safety notices.
• Effectively communicates with stakeholders at all organizational levels, including senior management, to ensure alignment with FCA plans and needs.
• Support the Regional Leads in responding to regulatory inquiries in a timely manner
• Supports internal audits, Notified Body, and FDA inspections in the backroom or front room.
• Identify and implement process improvement opportunities using Lean Sigma principles.
• Ensures process adherence and that documentation is “audit ready”.