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Participate as a core member of development teams to assure processes are in place to design and release highly reliable products
Provides Quality Assurance expertise and guidance for New Product Development, Manufacturing Operations, Supplier Development, and Product Quality
Aides in the assessment and qualification of new supplier materials such as component specifications and inspection standards
Maintain goals and metrics for existing and new products, regularly reporting on the progress to reach product objectives
Participates in supplier audits to drive process standardization and continuous improvement
Identify opportunities for reduced inspection of purchased materials based on risk and quality performance
Leads and facilitates failure investigations; ensuring mitigations and corrective actions are implemented in a timely manner
Contribute and lead component qualification deliverables such as process validation, first article inspection, and capability studies
Works with strategic partners and suppliers to ensure global awareness and compliance to procedures and specifications
Experience contributing to cross-functional product development teams
Experience with Quality, Project Management, and Process Engineering methodologies and tools
Demonstrated capability in successfully managing and leading change
Practice identifying, mitigating, and resolving risks
Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities
Demonstrated experience with data analysis, value stream mapping, 6‐Sigma, and Kaizen events preferred
Experience with electronic product life cycle (PLM) systems such as Agile or SAP
Practical experience in FDA and ISO regulated environments is a plus
Experience with statistical analysis packages such as JMP and Minitab is a plus
Ability to travel as needed
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.
BS or equivalent in a technical discipline with 5+ years of experience.
MS or PhD in a technical discipline with 3+ years of experience.
Experience working in a regulated environment, in-vitro diagnostics preferred.
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at email@example.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf