Quality Systems Analyst

Hydrogen UK Ltd; Irvine (CA); On-site; USD 56,000 - 63,000; Full time

Job summary

Hydrogen UK Ltd in Irvine, CA is seeking a Quality Systems Analyst to support supplier quality documentation remediation, including outreach, negotiation, and execution of Quality Agreements with external suppliers. This role serves as the primary point of contact for suppliers, ensuring timely escalation and closure.

Key activities include managing a portfolio of Quality Agreements, coordinating with Sourcing, Legal, and business stakeholders, and maintaining documentation, records, and metrics

Qualifications

• Experience in quality/manufacturing environments in the medical device industry.
• Proven MS Office proficiency and documentation skills.
• Strong negotiation and written/verbal communication abilities.

Responsibilities

• Own and progress a portfolio of Quality Agreements from outreach to execution.
• Serve as primary supplier contact for quality documentation matters.
• Escalate high-risk objections promptly and track resolution.
• Maintain project docs, communications, status reports, and metrics.

Skills

Quality systems

Supplier quality

MS Office

Project management

Negotiation

Communication

Documentation

Education

Bachelor's degree or equivalent in related field

Job description

Quality Systems Analyst

Location: Irvine, CA
Schedule: Standard
Duration: 9 Month Contract
Max Pay Rate: $40.50-45.55/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.

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