JOB TITLE: Supplier Quality Engineer
LOCATION: Irvine, CA
SCHEDULE: Standard working hours
DURATION: 24 Month Contract
PAY: $35-40 per hour
Job Responsibilities:
In this role, you will support supplier quality engineering activities focused on supplier qualification, receiving inspection, and component validation for the development, transfer, and launch of new Aortic transcatheter valve replacement delivery system devices. Key responsibilities include:
- Supporting supplier and receiving inspection activities for medical device components, ensuring quality and reliability requirements are met.
- Developing and implementing component inspection methods, inspection plans, and test method validations.
- Supporting component qualification activities, supplier process validation, and component capability assessments.
- Collaborating with engineering, manufacturing, suppliers, and cross-functional teams to resolve quality issues and support successful product launches.
- Applying data analysis and problem-solving techniques to identify risks, improve processes, and ensure product quality.
Essential Duties and Job Functions:
- Develop component inspection methods, inspection plans, and validation strategies for new and existing components.
- Perform test method validation and support supplier process validation activities.
- Conduct component capability assessments using statistical methods and data analysis techniques.
- Interpret engineering drawings, schematic diagrams, technical specifications, and computer-generated reports to determine quality requirements.
- Support engineering drawing reviews to ensure Design for Inspection (DFX) considerations are incorporated into product designs.
- Complete component qualification documentation and manage approval routing processes.
- Support receiving inspection and component inspections during milestone builds and product development phases.
- Investigate non-conformance issues, perform risk-based assessments, and support escalation activities when required.
- Collaborate with suppliers to identify root causes and implement corrective actions for quality concerns.
- Support transfer of receiving inspection processes to internal and external supplier sites.
- Apply quality engineering principles to support compliance with medical device quality systems and regulatory expectations.
- Work effectively with cross-functional teams to ensure project milestones and quality objectives are achieved.
Knowledge & Skills:
- Strong technical knowledge of quality engineering principles, inspection methods, and process validation.
- Strong written and verbal communication skills with the ability to collaborate across engineering, manufacturing, and supplier teams.
- Strong analytical, problem-solving, and critical-thinking abilities.
- Ability to interpret technical drawings, schematics, engineering specifications, and inspection requirements.
- Experience with statistical methods, data analysis, and quality improvement tools.
- Understanding of component qualification processes and supplier quality management practices.
- Experience developing inspection fixtures, test methods, and validation plans preferred.
- Detail-oriented with strong organizational skills and the ability to manage multiple priorities in a fast-paced environment.
- Ability to work independently, demonstrate initiative, and collaborate effectively within a team environment.
- Proficiency with computer applications and engineering software tools, including CAD and related technical applications.
- Ability to build productive working relationships with suppliers, vendors, and internal stakeholders.
- Commitment to following company policies, quality systems, and regulatory requirements.
Education & Experience:
- Bachelor’s degree in Engineering required.
- 0-2 years of relevant engineering experience required.
- Experience in supplier quality, manufacturing quality, component qualification, or medical device development preferred.
- Experience with inspection method development, validation activities, and statistical analysis is highly desirable.
- Familiarity with medical device quality systems and regulatory requirements is a plus.
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