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Associate Director, Quality Engineering (Device/combination Products)

Coherus BioSciences

This is a Full-time position in Houston, TX posted July 30, 2021.

Responsibilities Provide Quality engineering support to all assigned projects, manufacturing facilities and suppliers.

Function as a Quality Representative on Design/Development and Manufacturing project teams.

Ensure Design Control Elements are satisfied Design History File support Design Validation Design Reviews Design Verification plans, protocols, and reports Design Output Design Input Assist/conduct Failure Investigations and problem solving sessions for non-conforming product Demonstrate excellent interpersonal communication skills, which enable you work with multiple BD business units.

Consistent application of technical principles, theories, concepts and quality sciences / tools Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.

Contributes to the completion of specific programs and projects Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers Ability to effectively and clearly communicate ideas and knowledge to other individuals, teams and customers.

Independently determines and develops approach to solution May provide guidance and work direction to other team members Designs and performs development working independently within defined parameters with minimal supervision required Liaise with Manufacturing Plants Provide functional support to cross-functional teams Qualifications Education and Skills Bachelor Degree Science or related field Quality Engineering experience or 12 years industry experience (Healthcare/ Pharmaceutical) Thorough understanding of industry regulations QSR/cGMP, ISO QM standards Knowledge of design control principles (preferred) Thorough understanding of Statistical Methods for Quality Assurance Good written and oral communication skills Excellent problem solving and analytical skills Ability to handle multiple projects simultaneously in an unsupervised environment.

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