Quality Systems Analyst

Cynet SystemsSanta Ana, CA

About The Position

The Quality Systems Analyst will execute supplier outreach and manage a portfolio of Quality Agreements. This role involves communicating Quality System and regulatory requirements to suppliers, addressing their questions, and negotiating language within established guidelines. The analyst will collaborate with various internal departments to resolve supplier objections and drive execution. Maintaining project documentation, supplier communication records, and status reporting are key aspects of this position. The role also supports the remediation of Supplier Quality documentation and serves as a primary point of contact for suppliers regarding quality system requirements.

Requirements

  • 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.
  • Proven expertise in MS Office Suite.
  • Strong problem-solving and critical thinking skills.
  • Strong verbal and written communication skills.

Nice To Haves

  • Good project management skills and related software tools preferred.

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.
  • Support execution of Supplier Quality documentation remediation activities, including outreach, negotiation, and completion of Quality Agreements with external suppliers.
  • Serve as a primary point of contact for suppliers, working to secure agreement on quality system requirements while ensuring timely issue escalation and closure.
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