Quality Systems Analyst

Quality Systems Analyst

Location: Irvine, CA

Schedule: Standard

Duration: 9 Month Contract

Max Pay Rate: $40.50–45.55/hr




Summary:

The Quality Systems Analyst supports 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.




Job Responsibilities:

In this role, you will manage and support a variety of projects within the Supplier Quality department. Key responsibilities include:

• Executing supplier outreach and managing a portfolio of Quality Agreements
• Communicating Quality System and regulatory requirements to suppliers and addressing routine questions or concerns
• Negotiating language within established guidelines and identifying issues requiring escalation
• Collaborating with Supplier Quality, Sourcing, Legal, and business stakeholders to resolve supplier objections and drive execution
• Maintaining project documentation, supplier communication records, status reporting, and metrics to support leadership visibility and program execution

Essential Job Duties and Job Functions:

• Own and progress a portfolio of active Quality Agreements from outreach through execution
• Serve as the primary supplier point of contact for quality documentation matters
• Escalate unresolved supplier objections or high-risk issues in a timely manner
• Track and report status/metrics to leadership on a regular cadence

Knowledge and 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 negotiation and relationship management
• Strong problem-solving and critical thinking skills

Education and Experience:

• Bachelor's Degree or equivalent in a 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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