Basic Function and Scope of the Position:
In this role you will be responsible for the development of quality management processes supporting the software product development and bioinformatics activities in the Illumina Laboratory Services medical laboratory. This role will ensure that the software products and bioinformatic processes are in conformance to ISO 15189 and ISO 13485 standards. As a manager within the Quality Assurance for Clinical Services group this position will provide leadership, guidance and over site of software development, testing and bioinformatics activities for Illumina’s clinical laboratories. You will facilitate teams in identifying, documenting, assessing, correcting and preventing quality issues using risk analysis and root cause analysis tools. You will be responsible for quality planning and establishing and maintaining metrics to improve quality system processes, process capability, reliability and quality of products.
This role requires exceptionally strong communication, interpersonal and organizational skills and a solid understanding of the application of ISO 15189/13485/14971 or IEC 62304 standards.
Tasks and Responsibilities:
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Educational and Experiential Background:
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunities 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.
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