Supplier Quality Engineer

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

We are seeking a Supplier Quality Engineer to support supplier and receiving inspection activities for qualifying components in support of development, transfer, and launch of new Aortic transcatheter valve replacement delivery system devices. We are seeking a strong, highly collaborative engineer with solid technical expertise who enjoys working in a fast-paced and rapidly growing environment. The ideal candidate is a self-starter, will have excellent communication skills, and demonstrated skills in data analysis and problem solving. Specific experience in component qualification, inspection method and fixture development, test method and process validation, statistical methods, ability to work with cross-functional partners is preferred.

Job Responsibilities:

• Development of component inspection methods and plans, test method validation, component capability assessment, and validation of supplier processes.
• Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards. Support drawing reviews to ensure inspection DFX considerations are incorporated into designs
• Complete component qualification documentation and approval routing
• Support receiving inspection and component inspections for milestone builds. Manage investigation and risk-based escalation of non-conformance issues
• Support transfer of receiving inspection processes to other EW or supplier sites.

Skills:

• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Team player and detail oriented.
• Ability to make sketches, engineering drawings and common computations.
• Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.
• Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).
• Previous experience with Supplier qualifications, PPAP, component qualification is prefered.

Education/Experience:

• Bachelor's degree in engineering required.