The Quality Engineer will plan, coordinate and manage through completion, assigned projects designed to ensure continuous production and distribution of products consistent with established standards. Supervise and coordinate the activities of Quality Engineering staff. Identify and complete continuous improvement projects utilizing Six Sigma tools and methodologies. Evaluate compliance using relevant information and individual judgment to determine whether events or processes comply with specifications, operating procedures or standards. Duties and responsibilities are accomplished personally or through subordinate staff.
- Assists the Quality Manager in coordinating and executing objectives throughout the company in cooperation with other managers, to maximize product quality and operating system efficiency/effectiveness to minimize costs.
- Identify and coordinate resolution of system(s) inefficiencies that contribute to increased quality costs.
- Coordinates execution of validations, including creation of written protocols.
- Coordinates and participates in elements of investigations regarding customer complaints.
- Assesses results of Customer Complaint investigations and Corrective Actions for application, validity and conformance to FDA regulatory, ISO and Customer requirements. Makes recommendations under the direction of the Quality Manager.
- Utilize CAPA problem solving techniques to reduce internal and external failures. Selects sound techniques (FMEA, Design of Experiments, Cause and Effect, Flow Charts, SPC) to solve problems effectively. Assesses results for application, validity and conformance to specifications.
- Develops and analyzes statistical data in relationship to assigned projects to determine adequacy of present standards and establish proposed quality improvements. This includes analysis of current inspection methods and sample plans.
- Plans, promotes, performs and organizes training activities for internal departments and customers, related to quality engineering activities which include basic statistics, DOE, GR&R, Sample Plan designation; validation creation, control and oversight.
- Interacts with customers to assure mutual interpretation of specified requirements to ensure fulfillment of customer requirements and objectives are met.
- Assists in maintaining ISO and FDA QSR quality systems compliance.
- Generates and provides monthly and weekly project reports.
- Executes specific responsibilities as defined within the company quality operating system.
- Supports and maintains all policies of the company including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives.
- Bachelor’s degree in sciences or engineering discipline.
- Minimum three (3) years of experience within the quality profession. Healthcare industry and Drug Delivery systems experience preferred.
- Six-sigma and Lean black belt experience and training preferred.
- Ability to apply intermediate statistical knowledge (Mini-Tab, InfinityQS, VisualSPC)
- Excellent communication and organizational skills.
- Multi-lingual preferred. English is primary language.
- Ability to use common software productivity tools, such as Word, Excel and PowerPoint.
- Ability to understand and articulate how individual role interrelates with Quality department function, goals and objectives.
Rexam - 17 months ago
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