Analyst, Quality Systems

Target PR Range: 35-45/hr DOE

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