Senior Design Quality Assurance Specialist
2 days ago
About the Role:
We are seeking a Senior Design Quality Engineer to join our global quality team. As a key member of this team, you will be responsible for ensuring our products and processes meet customer performance needs.
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.
The ideal candidate will have a strong background in engineering and quality management principles, with experience in guiding teams through the execution of design control activities.
Responsibilities:
- Provide Quality oversight to ensure Illumina's products and processes are safe, effective, and meet customer performance needs throughout the product lifecycle.
- Support project planning, requirements/specifications development, design verification and validation, design transfer, process development, process validation, risk management, and/or human factors.
- Ensure products meet appropriate regulatory requirements (e.g. FDA, IVDR, ISO) in compliance with the quality management systems.
- Lead product risk management activities.
- Audit the quality and completeness of product Design History Files and/or Device Master Record.
- Facilitate participation in technical discussions and risk-based decision making utilizing knowledge of applicable technology.
- Utilize quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis).
Requirements:
- Bachelor's Degree Engineering and/or Science Degree with 5 years experience.
- Master's Degree Engineering and/or Science Degree with 3 years experience.
- 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.
About Us:
Illumina is 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.
Estimated salary: $120,000 - $180,000 per year.
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