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Position Summary:
Interfaces with development and supplier engineering to provide materials and components for company product manufacturing. Communicates product specifications to suppliers and assesses supplier's ability to meet engineering and quality requirements. Evaluates suppliers internal functions to assess their overall performance and provides feedback in assessment of their operation. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
Position Responsibilities:
Applies core knowledge and understanding of area of specialization to provide solutions in creative and effective ways.
Assesses unusual circumstances and uses sophisticated analytical and problem-solving techniques to identify cause and suggest variations in approach.
Works on assignments of diverse scope where information is limited and problem solving requires adaptation of existing techniques.
Enhances internal and external working relationships and networks with senior partners within area of expertise.
Adapts style to differing audiences and often advises others on difficult matters that require persuasion.
Work is done independently and is reviewed at critical points.
Uses evaluation, judgment, and interpretation to select best course of action.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Position Requirements:
Familiarity with FDA 21 CFR Part 820, ISO 13485, and supplier management processes (component qualification, risk assessments, and audits) an advantage.
Practical application of Problem Solving (CAPA/SCAR), Risk Management (FMEA), Non-conformance Handling, and continuous improvement tools.
Strong cross-functional collaboration, negotiation, and communication skills to manage relationships internally and externally.
Willingness to travel domestically and internationally as required (typically around 25%).
All listed requirements are deemed as essential functions to this position however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Experience/Education/Skills:
Bachelor's or master's degree in Engineering, Life Sciences, or related field.
Minimum 3 years specifically working as a Supplier Quality Engineer or in a closely related Supplier Relationship function. Demonstrated track record in component qualification, vendor audits, and supplier risk assessments.
Deep understanding of failure investigation (CAPA/SCAR), Risk Management (FMEA), First Article Inspection (FAI), and Mistake Proofing.
Illumina, Inc. is an American company. Incorporated on April 1, 1998, Illumina develops, manufactures, and markets integrated systems for the analysis of genetic variation and biological function. The company provides a line of products and services that serves the sequencing, genotyping and gene expression, and proteomics markets. Its headquarters are located in San Diego, California.
Job ID: 148862311
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