Quality System Analyst

Position Title: Analyst, Quality Systems

Work Location: Santa Ana, CA 92705

Assignment Duration: 9 Months

Work Arrangement: Onsite

Position 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.

Qualification & Experience:

• Experience in a quality and/or manufacturing environment in the medical device industry required
• Experience with Quality Agreements, including supplier outreach, negotiation, execution, remediation, and issue escalation.
• 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
• 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

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