Job Details

Job description:

Education/Experience:
3-5+ years of experience in the food, pharmaceutical and or supplement industry preferredKnowledge of regulatory requirements that affect the dietary supplement and/or pharmaceutical manufacturing business, preferredBachelor's in Food Science, Chemical Engineering, Chemistry or other Science related fieldASQ CQE or CQM preferredSupport for manufacturing and quality departments to improve overall product quality.
This is an excellent opportunity for an individual with strong engineering, quality and operations background. The Quality Engineer will 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 is critical for the successful implementation of the corrective actions. This role will interface closely with other cross-functional groups such as our Manufacturing, Engineering, R&D and Quality.

Job Summary:
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.
The Quality Engineer will lead and / or support thorough investigations of quality issues (CAPAs, 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.
Ensure 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.