MillenniumSoft Inc · 1 month ago
Supplier Quality Specialist - Urgent Need
MillenniumSoft Inc is a company focused on quality within the medical devices sector, and they are seeking a Supplier Quality Specialist. The role involves managing supplier quality activities, ensuring compliance with regulations, and supporting the Quality Management System.
Staffing & Recruiting
Responsibilities
Develop applicable Site / Unit procedures / work instructions and may make updates to Unit level procedures and policies
Serve as Supplier Quality associate for local and/or site-related suppliers (products and services)
Support identification suppliers and collaborate with cross-functional and/or WW team to complete supplier selection process
Implement supplier approval strategy. Facilitate, manage, and track supplier qualification and approval progress
Support Supplier creation/updates in Aravo
Manage and maintain Quality Agreements with suppliers, when needed
Provide on-going Supplier Quality Assurance support to all existing local and site-related suppliers
Collect and archive all relevant Supplier-related documentation
Support Supplier Quality performance monitoring
Support and/or conduct supplier quality audits / assessments, as needed
Manage changes initiated by suppliers. Coordinate with appropriate cross-functional teams
Support QA/QC lab with supplier activities related to product batch release and customer complaints as necessary
Lead or support problem-solving and root cause analysis activities (CAPA, Audits, Nonconformances, customer complaints, Supplier related complaints, etc.), as needed
Support internal and external audits as a subject matter expert, and support pre-and post-audit activities, as needed
Track trends of various quality data sources. Analyze and report on metrics
Support Site and WW Quality continuous improvement initiatives
Qualification
Required
US Citizens or GC Holders or GC EAD or OPT or EAD or CPT
Experience in supplier management activities
Ability to collaborate with quality leadership and other functions
Experience with Quality Management System
Knowledge of regulations, standards, and corporate requirements
Ability to develop Site / Unit procedures / work instructions
Experience in supplier selection process
Ability to implement supplier approval strategy
Experience with supplier qualification and approval progress tracking
Ability to manage and maintain Quality Agreements with suppliers
Experience in Supplier Quality Assurance support
Ability to collect and archive Supplier-related documentation
Experience in Supplier Quality performance monitoring
Ability to conduct supplier quality audits / assessments
Experience in managing changes initiated by suppliers
Ability to support QA/QC lab with supplier activities
Experience in problem-solving and root cause analysis activities
Ability to support internal and external audits
Experience in tracking trends of quality data sources
Ability to analyze and report on metrics
Experience in supporting continuous improvement initiatives