What are the responsibilities and job description for the Quality Engineer position at Denken Solutions?
Job Description
Currently, we are looking for talented resources for one of our listed clients. If interested please reply to me with your updated resume or feel free to reach out to me for more details at .
Title: Quality Engineer
Location: Prescott, AZ
Duration: 18 Months
Job Description:
- Under the direction of the Quality Manager, the Quality Engineer provides overall quality support for manufacturing/packaging 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, rejects 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 Manufacturing, Engineering, R&D and quality.
Responsibilities:
- Set 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/specifications requirements.
- Develops/authors verification, qualification and validation protocols (i.e. Validation Plans, IQ/OQ,PQ protocols, validations 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 (CAPA's, Non-Conformances, Audit Observations, OOS Investigations, 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.
- The Quality Engineer 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 included interactions with vendors or Supplier Development and Procurement Management for issues associated with raw materials and components.
- Other duties may be assigned as required.
Experience:
- 5 years of experience in the food, pharmaceutical and or supplement industry preferred.
- Knowledge of regulatory requirements that affect the dietary supplement and/or pharmaceutical manufacturing business, preferred.
- Education, Certification, Licenses & Registrations:
- Bachelor's in Pharmaceutical, Food Science, Chemical Engineering, Chemistry or other Science related field preferred.
- ***or other closely related discipline work with significant experience can be considered in lieu of a Bachelor's degree.
Skills:
- 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.).
- AS400 Knowledge desirable
- Knowledgeable of regulatory and GXP compliance requirements such as 21 CFR Part 111, HACCP, HARPC preferred.
- SQF practitioner/ FSSC/ BRC/ ISO experience 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 implements
- 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.
Expected high performance behaviors:
- Ability to work collaboratively within teams
- Ability to maintain effectiveness during major changes in work tasks or the work environment; adjusting effectively to within new work structures, processes, requirements or cultures.
- Continuously look for ways to do things faster and better, while maintaining high quality standards
- Is creative and intellectually curious; tries different and novel ways to solve obstacles
- Physical Demands
- Capable of lifting 40lbs
- Work environment may be exposed to powders, chemicals and allergens 9peanut, tree nut, milk, dairy, eggs, wheat, gluten, soy, fish and shellfish)
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