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Job Description:

· Responsible for providing quality engineering support for processes, materials, and products

· Assures that quality standards are maintained and Assist with the implementation and compliance of the quality management program.

· Support company goals and objectives, policies and procedures, quality systems, and FDA regulations.

Roles / Responsibilities:

· Coordinate and maintain the Corrective Action Program to assure appropriate investigation and implementation.

· Work with our suppliers on identifying and effectively implementing SCARs (supplier correction action requests).

· Liaise with Manufacturing Engineering on the drafting and implementation of validation process

· Liaise with Manufacturing Engineering on the completion of risk assessment for any product line extensions, process improvements or automation projects

· Provide quality support to Manufacturing Engineering with sampling plans, data processing or analysis for validation or risk assessment.

· Provide Quality input to support manufacturing process

· Assist in the analysis and resolution of problems that may reduce the efficient running of production lines

· Support and mentor Quality Inspectors

· Design and implement quality control process sampling systems, procedures, and statistical techniques

Skills / Experience:

· Bachelor's degree in related subject

· A minimum of 3 years industry highly regulated experience

· Familiarity with statistical tools

· Familiarity with FMEAs and root cause analysis tools