Supplier Quality Engineer - Component & Process Validation

Planet Pharma; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Planet Pharma in Irvine, CA is seeking a Supplier Quality Engineer to support supplier and receiving inspection activities for qualifying components in development, transfer, and launch of new Aortic transcatheter valve devices. You will collaborate across teams, apply data analysis, and contribute to process validation and fixture development.

The ideal candidate has strong communication, problem-solving, and drafting skills, with experience in CAD and blueprint interpretation.

Qualifications

• Bachelor's degree in engineering is required.
• Experience with component qualification, inspection methods, PPAP and supplier qualifications is preferred.

Responsibilities

• Develop component inspection methods and validation plans, assess component capability, and validate supplier processes.
• Interpret drawings, schematics, or formulas and confer with management to ensure quality and reliability standards; support drawing reviews for DFX considerations.
• Complete component qualification documentation and approval routing.
• Support receiving inspection and component inspections for milestone builds; manage investigations and risk-based escalation of non-conformance issues.
• Support transfer of receiving inspection processes to other EW or supplier sites.

Skills

Creativity

Communication

Analytical thinking

Problem solving

Team player

Detail oriented

Drafting

Blueprints

Education

Bachelor's degree in engineering

Tools

CAD

Job description

Planet Pharma in Irvine, CA is seeking a Supplier Quality Engineer to support supplier and receiving inspection activities for qualifying components in development, transfer, and launch of new Aortic transcatheter valve devices. You will collaborate across teams, apply data analysis, and contribute to process validation and fixture development.

The ideal candidate has strong communication, problem-solving, and drafting skills, with experience in CAD and blueprint interpretation.