Quality Engineer

Quality Engineer
Must have BS or BA in Scientific field (Biology, Biotechnology, Chemistry)
Position Summary:POSITION SUMMARY:Engineer quality implementation throughout the development of in vitro diagnostic devices, including their transfer from Research and Development to Manufacturing. Collaborate with the director for each IVD development project to ensure quality. Perform operations as described by Standard Operating Procedures (SOPs) under Good Manufacturing Practices (GMP's). Work closely with other manufacturing support areas to coordinate activities and participate as an active member of cross-functional teams. Participate in the transfer of products from Product development to manufacturing.
REQUIREMENTS
Provide leadership, as facilitator, within the Company for quality function deployment
Develop product specifications, process capability indices (Cp, Cpk, …) and sampling plans based on customer requirements and Design-Of-Experiments testing
Manage product and process design from a business excellence perspective (Lean and Six Sigma, robust design, full-factorial experiments, Taguchi designs)
Manage product and process control from a business excellence perspective, including defining, classifying, evaluating and controlling quality characteristics and defects using six sigma, risk management and statistical process control tools
Manage continuous process improvement and cost of quality
Use quantitative methods and tools to ensure quality
Perform related duties as required
Work as a team member to ensure that department and company goals and objectives are met
Comply with all departmental and company required training.