The Quality Engineer II is responsible for analyzing and ensuring the reliability and quality of molecular diagnostic products, the product development process, production processes, and patient results. Individual must be self motivated and able to balance multiple priorities and tight deadlines with minimal supervision.
Leads cross functional teams to identify and capitalize on continuous improvement opportunities by applying methodologies such as Lean and Six Sigma across the organization. Opportunities are assessed and prioritized based on their relevance to quality metrics.
Leads and supports in the planning and execution of validation activities, with a focus on equipment, chemistry, and process validation.
Designs experiments in collaboration with technical experts, selecting appropriate sample sizes, and analyzes resulting data with statistical software tools. Communicates results effectively verbally and through written test summary reports.
Collects, compiles, and evaluates data over time to create quality metrics. Achieves this objective using SQL queries, statistical tests, statistical process control (SPC), and statistical analysis software. Maintains automated SPC system.
Lead cross-functional teams to assess and mitigate risk by utilizing control strategies, statistical tools, and statistical process control (SPC).
Supports the internal quality system and consults in the preparation of technical documents for review and submission to regulatory and accrediting agencies.
Meets minimum education and experience requirements:
Minimum of a Bachelor’s degree in Engineering and 5+ years of experience, OR
Master’s degree in engineering plus 3+ years of experience
Certified Lean Six Sigma Black Belt
Certified ASQ Quality or Reliability Engineer
Experience with FDA, and other regulatory requirements in a regulated environment.
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