Quality and Regulatory Coordinator

Req ID: 6969

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 Field Corrective Action Coordinator provides important support to the Field Corrective Action Team to assist in the timely execution and closure of Field Corrective Actions. The coordinator will work with the team in implementing FCAs in the region, assist in FCA reconciliation and work with the global team on developing responses to Regulatory Authorities on FCA actions. The role requires a detailed oriented professional with strong written and verbal communications skills able to work efficiently and effectively under tight timelines.

Job Duties

Implementation and reconciliation management of Field Corrective Actions
Assist in the development and responses to Regulatory Authorities for Field Corrective Actions
Assist with any coordination work with Quality teams handling shipping holds.
Maintain KPIs Dashboard, and FCA related documentation for audit readiness.
Managing internal/ external service providers supporting the process: Sales, Service, Logistics, Finance, Legal, etc.
Work in an international context within the Global Quality and Regulatory Team

Job Qualifications

Required:

2 year or 4-year College/post-secondary degree.
Minimum 5 years of work experience in roles involving written business communication and record retention.
Work experience in a regulated industry or quality management system preferred.
Proficient with standard functions in Microsoft tools (Word, Excel, Teams, etc.)
Demonstrated strength in business communication, particularly written communication.

#LI-Hybrid

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.

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.

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley ||

Nearest Major Market: Allentown
Job Segment: QA, Quality Assurance, Quality Manager, Quality, Technology

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