Quality Engineer

Roles & Responsibilities

• Provides product team support for multitude of new product development activities (e.g. engineering testing, design and process characterization, and other V&V activities)
• Aids in conducting Quality Assurance documentation reviews and audits as needed
• Supports execution of risk management activities
• Supports development and execution of relevant process development and validation activities (e.g. IQ/OQ/TMV/APQ)
• Utilizes multifaceted industry and process excellence standards in daily quality operations, including, but not limited to, good manufacturing practices (GMP) and Good Documentation Practices (GDP)
• Affords assistance in addressing product or process issues (internally or externally manufactured) or in investigating customer complaints as needed
• Serves as a liaison for handling complex technical issues for manufacturing processes that are to be transferred to satellite facilities
• Collaborates with cross-functional teams to achieve project team goals and objectives

Education & Experience

• A minimum of a bachelor's degree required (preferably in Engineering or related technical field); or a minimum of 2 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry
• Ability to develop and implement Quality standards
• Thorough knowledge of Quality systems and processes, including GMP and QSR requirements for medical devices
• Knowledge of new product development design controls, and verification and validation (V&V) tools and methodologies
• Demonstrated problem solving skills
• Certified in American Society for Quality (ASQ) or Six Sigma experience, and/or knowledge of Process Excellence tools
• Knowledge of GD&T (Geometric Dimensioning and Tolerancing)
• Expertise in NPD (New Product Development) process and Design/Process Validation
• Knowledge of statistical analysis tools such as Minitab is a plus