Associate Director, Quality Engineering (Device/Combination Products)

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.