Quality and Process Improvement Coordinator - Global Ship Hold Center (GSHC)

Working Location: NATIONWIDE 

Workplace Flexibility: Field

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

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Job Description

The role of a Quality and Process Improvement Coordinator – 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 GxP, quality documentation, system workflows, and relevant compliance policies. This role also acts as liaison between RA/QA, Business Groups, Outbound and Inbound staff to coordinate all physical and system inventory transactions that pertain to regulatory issues, Warehouse Management System/ERP Item Master updates, shortages, returned inventory, damages/disposals, slotting, location type availability and size to improve efficiencies while maintaining Inventory Integrity.

Job Duties

• Monitor and manage current global ship hold process ensuring adherence to the established processes and clearing bottlenecks with workflow & approval flows.
• 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.
• Address and coordinate with RA/QA on quality issues which include verifying, segregating and returning stock where applicable.
• Process Return to Vendor and Destruction orders as requested. Coordinate receipt of all necessary paperwork needed to initiate and confirm destruction orders.
• Handle the internal product transfers shipments for disposition of Ship Hold Materials.
• Work on problems of moderate scope where analysis of situations or data may be required.
• Collaborate with cross-functional teams to design and implement process improvement initiatives.
• Build productive and stable working relationships with internal functional teams and may interact with cross-functional teams with some support and supervision from senior team members.
• Provide training and support to staff on quality standards and best practices.
• Serve as a Subject Matter Expert (SME) and point of contact for all GSHC activities

Job Qualifications

Required:

• Associate’s degree in quality or a closely related field or combination of education and relevant experience.  Bachelor’s degree in quality, or business or equivalent knowledge is preferred.
• 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:

• Minimum of 3 years’ experience working in a regulated environment such as FDA, ISO 13485, and/or medical device company is preferred.
• Demonstrate strong project management and organizational skills, multitasking ability, and work effectively with internal stakeholders across functions.