Senior Global Field Corrective Action Manager

Working Location : PENNSYLVANIA, CENTER VALLEY

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.

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

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 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.

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 .

Job Qualifications

Required :

• Bachelor’s degree in business, sciences, quality management or related field, or equivalent professional experience or demonstrated equivalent professional experience.
• Minimum of 8 years of experience with medical devices is required.
• Demonstrated experience leading cross-functional teams and hands-on leadership / accountability for completing programs and projects with aggressive timelines.
• Enter special considerations such as work hours (overtime / on-call) or travel

Preferred :

• Minimum of 5 years of experience in design assurance or a post-market quality function is preferred.
• Experience interacting with regulatory bodies is preferred.
• Lean Sigma green belt or higher is preferred.
• Excellent verbal and written communication skills, with the ability to interact with all levels of the organization.
• Excellent working knowledge of project management skills
• Strong attention to detail
• Ability to operate efficiently, proactively, and effectively in a fast-paced environment.
• Must be able to work independently, self-motivated, a sense of ownership with a strong sense of urgency to drive for results.
• Proven analytic and problem-solving skills.
• Strong stakeholder management and ability to influence and coach others.
• Proficient use of software applications such as MS Windows, MS Office (Word, Excel, PowerPoint).

Why join Olympus?

Here, people matter our health, our happiness, and our lives.

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive Medical, Dental, Visions coverage effective on start date
• 24 / 7 Employee Assistance Program
• Free virtual live and on-demand wellness classes
• Work-life balance supportive culture with hybrid and remote roles
• 12 Paid Holidays
• Educational Assistance
• Parental Leave and Adoption Assistance
• Volunteering and charitable donation match programs
• Diversity & Inclusion Programs including Colleague Affinity Networks
• On-Site Child Daycare, Café, Fitness Center
• US Only

Limited locations

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you.

Learn more about our benefit offerings at https : / / www.olympusamerica.com / careers / benefits-perks .

The anticipated base pay range for this full-time position working at this location is $101,523.00 - $142,132.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).

Olympus considers a variety of factors when determining actual compensation for this position including : level of experience, working location, and relevant education and certifications.

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 .

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect.

We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and / or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and / or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Applicants with Disabilities : As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone.

If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.

com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Posting Notes : United States (US) Pennsylvania (US-PA) Center Valley Quality & Regulatory Affairs (QA / RA)