Quality Analyst

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