Quality Systems Analyst

Quality Systems Analyst

Location:

Irvine, CA

Schedule:

Standard
Duration: 9 Month Contract
Max Pay Rate: $/hr

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.

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

• 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

• 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

• 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