In this Cross-functional quality role, you will actively participate in product development and transfer activities for Assays, Array and Automation development programs, including research and in vitro diagnostic (IVD) applications. You will be responsible for guiding teams through the execution of design control activities in alignment with quality system requirements and current best practices to ensure Illumina’s products and processes are safe, effective, and meet customer performance needs. You will represent quality on cross functional core project teams.
• Provide design control leadership to new product development teams, with a focus on Assays, Array and Automation development projects.
• Provide support for project planning, requirements/specification development, product development, design verification, design transfer, process development, process validation, risk management, human factors and design validation activities.
• Lead product risk management activities.
• Audit the quality and completeness of project design history files.
• Provide consultation to design and process owners with regards to design verification and design validation protocols and reports. Support clinical study planning as needed.
• Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making.
• Support issue resolution using a risk-based approach.
• Ensure product development and validation programs meet regulatory requirements when applicable.
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.
• Sr. Design Quality Engineer: minimum of 5 years of related experience
Staff Design Quality Engineer: minimum of 8 years of related experience
• Technical expertise in product development with focus on reagent, assay, consumable development.
• Experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, IEC62304, IVDD, IVDR , and GCP)
• Practical experience in design controls, risk management, verification, validation and change control, and failure investigation tools and techniques
• Applied experience with quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, and trend analysis)
• Highly effective communication, facilitation, coaching, and negotiation skills
• Adaptable to fast-paced, dynamic work environment with shifting demands
• Demonstrated ability to accomplish goals while working across departments is required
•Bachelor’s degree or higher in an engineering or technical science discipline
At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. 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 require accommodation to complete the application or interview process, please contact firstname.lastname@example.org. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf