Sr Design Quality Engineer
About The Position
In this cross functional quality role, you will actively participate in design control activities, including research and diagnostic applications. You will ensure product and process conformance to applicable safety and quality system regulations and standards (e.g. FDA (820), ISO 13485, ISO 14971, IVDR). 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 the company's products and processes are safe, effective, and meet customer performance needs. You will represent quality on cross functional project teams.
Requirements
- Bachelor's Degree in Engineering or Science field with 5+ years of related experience, or Master's Degree with 3+ years of related experience
- PhD Engineering and/or Science Degree with 2+ years experience
Nice To Haves
- PhD Engineering and/or Science Degree with 2+ years experience
- Quality Certification (e.g. CQE) Upon Hire
- Technical expertise in products such as reagents, consumables, assays, instruments preferred
- Knowledge of quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis)
- Knowledge of FDA regulatory environment (CFR 820), 501k, ISO 14971, ISO 13485 and IVDR preferred
- Highly effective communication, facilitation, coaching, and negotiation skills
- Adaptable to fast-paced, dynamic work environment with shifting demands
- Must be detailed oriented, well organized and able to work independently and in teams
Responsibilities
- Provides Quality oversight to ensure Illumina’s products and processes are safe, effective, and meet customer performance needs throughout the product lifecycle
- Provides support for project planning, requirements/specifications development, design verification and validation, design transfer, process development, process validation, risk management, and/or human factors
- Ensures products meet appropriate regulatory requirements (e.g. FDA, IVDR, ISO) in compliance with the quality management systems
- Leads product risk management activities
- Audits the quality and completeness of product Design History Files and/or Device Master Record
- Facilitates participation in the technical discussions and risk-based decision making utilizing knowledge of applicable technology
- Provides management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
- Utilizes quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis)
Benefits
- access to genomics sequencing
- family planning
- health/dental/vision
- retirement benefits
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
