Quality Analyst - Global Ship Hold Center (GSHC)

Working Location: 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, coupl