Analyst, Quality Systems

Summary:
"The Analyst, Quality Systems is responsible for supporting execution of Supplier Quality documentation remediation activities, including outreach, negotiation, and completion of Quality Agreements with external suppliers. This role serves as a primary point of contact for suppliers, working to secure agreement on quality system requirements while ensuring timely issue escalation and closure.

Key Responsibilities:
" Execute supplier outreach and manage a portfolio of Quality Agreements
" Communicate Quality System and regulatory requirements to suppliers and address routine questions or concerns
" Negotiate language within established guidelines and identify issues requiring escalation
" Collaborate with Supplier Quality, Sourcing, Legal, and business stakeholders to resolve supplier objections and drive execution
" Maintain project documentation, supplier communication records, status reporting, and metrics to support leadership visibility and program execution

Additional Skills:
" Experience in a quality and/or manufacturing environment in the medical device industry required
" Proven expertise in MS Office Suite
" Good project management skills and related software tools preferred
" Excellent written and verbal communication skills including negotiating and relationship management skills
" Strong problem-solving and critical thinking skills

Education and Experience:
" Bachelor's Degree or equivalent in in related field of study
" Experience in a quality and/or manufacturing environment in the medical device industry required
" 2-4 years of experience required