Analyst, Quality Systems

Ultimate Staffing; Irvine (CA); On-site; USD 65,000 - 95,000; Full time

Job summary

Ultimate Staffing in Irvine, CA is seeking an Analyst, Quality Systems to support the remediation of supplier quality documentation and to secure Quality Agreements with external suppliers. You will serve as the primary contact for suppliers, ensuring timely escalation and closure in alignment with quality system requirements.

This role emphasizes negotiation, collaboration with multiple stakeholders, and maintaining comprehensive project records to enable leadership visibility and program

Qualifications

• Bachelor's degree (or equivalent) in a related field.
• 2–4 years of experience in quality/manufacturing within the medical device industry.
• Experience supporting supplier quality documentation remediation and quality agreements.

Responsibilities

• Execute supplier outreach and manage a portfolio of Quality Agreements.
• Communicate Quality System and regulatory requirements to suppliers and address routine questions.
• Negotiate language within established guidelines and escalate issues as needed.
• Collaborate with Quality, Sourcing, Legal and stakeholders to resolve objections and drive execution.
• Maintain project documentation, supplier communication records, status reporting, and metrics.

Skills

Quality management

Project management

Negotiation

Relationship management

Written and verbal communication

Problem solving

Education

Bachelor's degree or equivalent

Tools

Quality software tools

Job description

The Analyst, Quality Systems is responsible for supporting 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.

Key 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

Additional Skills

• Experience in a quality and/or manufacturing environment in the medical device industry required
• Good project management skills and related software tools preferred
• Excellent written and verbal communication skills including negotiating and relationship management skills
• Strong problem-solving and critical thinking skills

Education and Experience

• Bachelor's Degree or equivalent in in related field of study
• Experience in a quality and/or manufacturing environment in the medical device industry required
• 2-4 years of experience required

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.