Quality Assurance Specialist managing and executing quality assurance for Duck Creek implementations and releases. Overseeing test planning, execution, defect management, ensuring high - quality deliveries.
About the role
- Staff Quality Process Engineer for GRAIL working on quality engineering projects and compliance. Leading initiatives for early cancer detection technologies in North Carolina.
Responsibilities
- Lead and execute high-impact quality engineering projects that improve product quality, reliability, and compliance.
- Develop, implement, and maintain advanced quality control processes, statistical methods, and risk management practices.
- Lead complex root cause investigations and corrective/preventive action plans, ensuring systemic issues are addressed.
- Partner with engineering, manufacturing, and supply chain teams to design and optimize processes for quality and efficiency.
- Provide technical expertise in measurement system analysis, process validation, and statistical process control.
- Serve as a subject matter expert during internal audits, regulatory inspections, and customer quality assessments.
- Prepare and present quality metrics, trend analyses, and recommendations to senior leadership.
- Mentor and coach junior and mid-level engineers, promoting knowledge sharing and development across the team.
Requirements
- Bachelor's degree in Engineering, Quality Assurance, Industrial Technology, or a related field with 8–12 years of relevant work experience in quality engineering, process engineering, or manufacturing; OR Master's degree with 5–8 years of relevant experience; OR PhD with 2–5 years of relevant experience.
- Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:
- GMP quality management systems (e.g. ISO 13485)
- Risk assessment frameworks (e.g. ISO 14971)
- Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)
- Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)
- Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)
Benefits
- flexible time-off or vacation
- 401(k) retirement plan with employer match
- medical, dental, and vision coverage
- carefully selected mindfulness programs
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