Quality Engineer

Job Description

• Participate in quality improvement initiatives to reduce defects and quality issues, and make recommendations to improve the production process based on findings from quality analysis.
• Collaboration across multiple disciplines, which is critical for the successful implementation of the corrective actions.
• Interface closely with other cross-functional groups such as our Manufacturing, Engineering, R&D and Quality.
• Sets and monitors SPC data to ensure delivery of consistent quality. Utilize basic statistical tools to analyze for trends or issues.
• Develops and analyzes statistical data and specifications to establish product and process capabilities (Cp/Cpk).
• Identify, develop, and implement process controls to meet customer/specification requirements.
• Develops/authors verification and validation protocols (i.e. Validation Plans, IQ/OQ/PQ protocols, validation summary reports).
• Assists and coordinates equipment, cleaning and process validations.
• Participate in and support the maintenance of the Quality Management System and Maintain Quality Department business metrics.
• Lead and / or support thorough investigations of quality issues (CAPA’s, Non-Conformances, Audit Observations, etc.) ensuring effective corrective and / or preventive actions occur.
• Participate in cross-functional teams on process control, improvement, and optimization projects; participate in other continuous improvement projects.
• Performs assessments of any given quality system to determine the effectiveness and dependability of such system. 
• Ensures all quality specifications are met for any given product or procedure and suggests methods to bring equipment and work procedures into compliance with quality control standards.
• Direct support of project activities and all other associated Quality functions.
• Assist in investigations, which includes interactions with vendors or Supplier Development and Procurement Management for issues associated with raw materials and components.

Qualifications

• 5+ years of experience in the food, nutraceutical, pharmaceutical and or supplement industry preferred.
• Ideal candidate has experience with solid-dose techniques (including Mixing, Blending, Tableting, Encapsulating and Coating).
• Knowledge of regulatory requirements that affect the dietary supplement and/or pharmaceutical manufacturing business, preferred.
• Bachelor’s in Pharmaceutical, Food Science, Chemical Engineering, Chemistry or other Science related field preferred or other closely related discipline with extensive significant experience can be considered in lieu of a Bachelor’s degree. 
• ASQ CQE or CQM preferred 
• Must be proficient with PC programs, i.e. Microsoft Office (Word, Excel, PowerPoint)
• Problem solving and statistical skills using quality tools (Pareto analysis, statistical process control, multi-variant DOE etc.).
• Knowledge of regulatory and GXP compliance requirements such as 21 CFR Part 111, HACCP, HARPC preferred
• Strong analytical skills; able to use data, communicate key trends, develop and execute continuous improvement plans.
• Six Sigma Green Belt preferred
• Ability to work with cross-functional groups to implement improvements
• Strong organizational skills; ability to manage multiple tasks and work well under pressure
• Demonstrated ability to work effectively with individuals at all levels of the organization.
• Demonstrated ability to use influencing skills to accomplish goals and objectives
• Capable of lifting 40 lbs.
• Work environment may be exposed to powders, chemicals and allergens (peanuts, tree nuts, milk, dairy, eggs, wheat, gluten, soy, fish and shellfish)

Additional information