Working Location: NATIONWIDE; PENNSYLVANIA, CENTER VALLEY

Workplace Flexibility: Field

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 Olympus Global Ship Hold Center (GSHC) is dedicated to managing the end-to-end process and execution of ship holds, with a mission to establish a standardized and streamlined approach across regions. This involves centralizing decision-making authority, ensuring consistency, and utilizing a dedicated tool to enhance global visibility. The role of a Quality Analyst – Global Ship Hold Center (GSHC) is overseeing and maintaining the quality and compliance of GSHC delivery GSHC records, with a strong emphasis on adherence to GDP, quality documentation, system workflows, and relevant compliance policies. It involves reporting, analyzing, and evaluating GSHC records for quality and compliance.

Job Duties

• Monitor and manage current global ship hold process ensuring adherence to the established processes and clearing bottlenecks with workflow & approval flows.

• Administrator for the Microsoft Power Application, GSHC – Manage email/workflow communication group; provide application access rights to requesters.

• Tiers 1 & 2 help support.

• Provide “customized” Power BI reporting & dashboards to support key stakeholder groups.

• Responsibilities include recognizing opportunities to enhance process and/or system monitoring, identifying issues, and proposing potential solutions. The GSHC team will function to provide key performance indicators (KPIs) used for process monitoring and management reviews.

• Utilize Microsoft Power Platform to help drive process improvement.

• Manage application documentation and record reconciliation; training materials; Standard Operating Procedures and Work Instructions.

• The Quality Analyst plays a significant role in ensuring the organization's GSHC records and processes operate with efficiency, effectiveness, and compliance with quality and regulatory standards. Additionally, this role entails ensuring that GSHC complies with required quality standards, such as the FDA Quality System Regulation and ISO 13485.

• In this role, you will report to the Director of Global Ship Hold Center, and will work closely with the following groups:

• Quality Assurance/Regulatory Affairs (QA/RA): Ensures compliance with quality standards and regulatory requirements.

• Supply Chain Management (SCM): Enhances efficiency in the supply chain by preventing disruptions.

• Warehouse & Distribution Centers: Facilitates better management of inventory and timely product release.

• Executive Management: Provides leadership with comprehensive insights into global ship hold activities.

• Compliance Audits: Supports seamless and transparent compliance audits through centralized data management.

• Audit to GSHC processes and policies as it pertains to the Quality Management System (QMS).

• Serve as a Subject Matter Expert (SME) and point of contact for all GSHC activities,

• Report, troubleshoot, monitor, and manage the open Ship Holds in the GSHC Application to ensure process compliance.

• Manage reporting and create dashboards to support performance accuracy and identify trends.

• Recommend and assist in creating materials for presentations, communications, and meetings/training as well as delivering training.

• All duties as assigned.

Job Qualifications

Required:

• Bachelor’s degree in business or equivalent knowledge required

• Minimum of 2 years’ experience working in a regulated environment such as FDA, ISO 13485, and/or medical device company required.

• Proficiency in Microsoft Office, including Excel, Word, PowerPoint, and Visio is required.

• Role is Global and can be performed as a #LI-Remote in USA or Europe.

Preferred:

• Familiarity with Power Platform as well as developing dashboards utilizing Power BI reporting or willingness to learn.

• Experienced in working with software systems and preferably have knowledge of ERP Systems.

• Knowledge of FDA regulations, ISO 13485 and HIPAA for medical devices preferred.

• Quality auditing skills preferred.

• Adept in robust troubleshooting and analytic skills, coupled with an extraordinary attention to detail.

• Effective written and verbal communication skills, including process writing.

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 $62,499.00 - $84,374.00 / 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)