Quality Engineer

DUTIES AND RESPONSIBILITIES:

• Developing and implementing technically complex methods and procedures for process control, process improvement, sanitation, testing and inspection to ensure that the products and systems are free of flaws and function as designed
• Developing and reviewing validation programs to ensure sophisticated processes and equipment operate to consistently produce quality products
• Analyzing supplier, operation and customer data, complaints and defective products to determine trends and recommends corrective / preventative actions
• Interfacing with suppliers, operations, customer and regulatory representatives concerning quality problems, ensures effective corrective action is implemented and develops prevention-based quality improvement programs
• Leading strategic quality improvement initiatives and teams or participates as QA lead for cross-functional initiatives including but not limited to equipment qualification, validation, value chain projects and new product launches
• Representing customer to resolve product design and quality issues
• Ensuring that products, materials and services comply with established specifications and technical requirements through application of quality tools and principles
• Designing the appropriate models and tools for ensuring effective communication, delivery and training of quality programs, processes and systems (including cGMP, ISO, HACCP, Sanitation, etc.)

QUALIFICATIONS:

• Quality assurance / quality control experience supporting cosmetics, personal care, dietary supplement, food or OTC liquid fill manufacturing operations
• Sanitation and Good Manufacturing Practices (GMPs)
• Broad range of manufacturing operations with experience assessing quality risks in a variety of manufacturing settings
• Effectively communicating both verbally and written at all levels (horizontally and vertically / internally and externally)
• Investigating process deviations to identify root cause and effective preventive measures
• Organized and detail-oriented with the ability to independently recognize and balance changing priorities to include interruptions, deadline revisions and managing of critical shipments / production orders
• Efficiently and professionally completing tasks and projects with a high standard of accuracy and presentation
• Equipment/facilities qualification, process and cleaning validation
• Planning, organizing, monitoring and controlling projects; ensuring efficient utilization of technical resources and appropriate mitigation of risk to achieve project objectives
• BS/MS Science or Engineering 5-10 years proficiency