In this cross functional quality role you will actively participate in product development and transfer activities, as well as product field and internal quality initiatives, ensuring product and process conformance to FDA and ISO 13485 standards. This role will serve as a resource to product development and manufacturing to improve product quality, reliability, and process capability. This position will be involved in product quality investigations and responsible for identifying and championing sustainable supplier quality improvements. 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 FDA and ISO 13485 standards.
• Participate in product development and transfer activities, as well as product field and internal quality initiatives, ensuring product and process conformance to FDA and ISO 13485 standards.
• Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, risk management, and specification development.
• Serve as the custodian of the Device Master Record during new product introduction, ensuring its completeness and accuracy.
• Serve as a resource to product development and operations to improve product quality, reliability, and process capability.
• Trend, analyze, and report on quality data to improve product and process; develop recommendations based on data analysis.
• Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making.
• Drive product risk management activities and ensure quality and completeness of product device master record, validation packages, and change orders.
• Facilitate teams in identifying, documenting, assessing, correcting, and preventing quality issues using risk analysis and root cause analysis tools.
• Provide consultation to end users and process owners with regard to data collection, analysis and creation of validation reports.
• Coordinate issue resolution using a risk-based approach.
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.
• Take initiative to identify and drive improvements to the Illumina quality system.
• Minimum 5 years’ experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferred.
• Quality Certification preferred (e.g., CQE)
• Experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, IEC62304, GAMP5, IVDD, ISPE Baseline Guides, and ASTM E2500-07 Verification Guideline)
• Practical experience in design controls, risk management, validation, change control, and supplier quality
• Experience with CAPA and failure investigation tools and techniques
• Applied experience with quality and statistical analysis tools (e.g. SPC, 6 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 in an engineering or science discipline; advanced degree 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 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