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)
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