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
...