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The Quality Validation Engineer is responsible for planning, coordinating and managing through completion, assigned projects to ensure the development and production of products meets customer and internal quality deliverables. Coordinate and lead investigations regarding customer complaints. Work with Supply Chain management to evaluate and manage supplier performance.
Job Responsibility:
Assists the Quality Manager in coordinating and executing objectives
Identify and coordinate resolution of system inefficiencies
Coordinate and manage the execution of validations and creation of written protocols
Coordinate and manage the execution of change control activities
Assess results of Customer Complaint investigations and Corrective Actions
Utilize CAPA problem solving techniques
Develop and analyze statistical data
Evaluate compliance using relevant information and individual judgment
Develop product specifications for existing products
Plan, coordinate, and manage assigned Supplier Quality evaluations
Interact with suppliers
Support implementation and management of quality agreements with assigned suppliers
Plan, promote, perform and organize training activities
Interact with customers
Assist the Quality Managers during customer audits
Assist in maintaining ISO and FDA QSR quality systems compliance
Execute specific responsibilities as defined within the company quality operating system
Support and maintain all policies of the company
Identify and complete continuous improvement projects utilizing Six Sigma tools
Requirements:
Bachelor’s degree in Engineering, Science or related field required
3+ years' of experience in a Quality position strongly preferred
Experience in the Medical Device industry strongly preferred (ISO13485)
Experience with technical writing, IQ/OQ/PQ is preferred
Experience with equipment validation is preferred
Experience working onsite in Manufacturing is strongly preferred
Excellent communication skills with the ability to understand, read, write and speak English required
Must have the ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge
Six-sigma experience, training or certification preferred
Intermediate level computer skills, including Microsoft Office applications required
SAP experience preferred
Ability to work independently from verbal and/or written instructions required
Ability to understand and articulate how individual role and responsibilities tie into Quality department function, goals and objectives