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Validation Engineer
3 months ago
Job Description
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.
Responsibilities:
- Assists the Quality Manager in coordinating and executing objectives throughout the company in cooperation with other departments, to maximize product quality and operating system efficiency/effectiveness while minimizing cost
- Identify and coordinate the resolution of system inefficiencies that contribute to increased quality costs.
- Coordinate and manage the execution of validations and the creation of written protocols.
- Coordinate and manage the execution of change control activities.
- Assess results of Customer Complaint investigations and Corrective Actions for application, validity, and conformance to FDA regulatory, QSR, ISO and Customer requirements.
- Utilize CAPA problem-solving techniques to reduce internal and external failures, select sound techniques (FMEA, Design of Experiments, Cause and Effect, Flow Charts, SPC) to solve problems effectively, and assess results for application, validity and conformance to specifications.
- Develop and analyze statistical data in relationship to assigned tasks to determine adequacy of present standards and establish proposed quality improvements, including analysis of current inspection methods and sample plans.
Requirements:
- Bachelor’s degree in Engineering, Science or related field.
- 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
- Experience working onsite in Manufacturing
