Analyst, Quality Systems

Planet Pharma; Irvine (CA); On-site; USD 48,000 - 62,000; Full time

Job summary

Planet Pharma in Irvine, CA is seeking an Analyst, Quality Systems to support supplier quality documentation remediation and secure Quality Agreements with external suppliers. This role serves as the primary contact for suppliers while ensuring timely escalation and closure of issues.

The ideal candidate will have 2–4 years of experience in a medical device quality environment, strong MS Office skills, and proven negotiation and communication abilities to collaborate with Quality, Sourcing,

Qualifications

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

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

Skills

Quality systems

MS Office Suite

Project management

Negotiation

Communication

Problem solving

Education

Bachelor’s Degree or equivalent

Tools

MS Office Suite

Job description

Target PR Range: 35-45/hr DOE

Summary:

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
• Proven expertise in MS Office Suite
• 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