Senior Quality Engineer

Position Summary

The Senior Quality Engineer is responsible for leading the Quality Engineering team to improve quality, production, and processing methods and controls in manufacturing to achieve operational excellence. This position requires the ability to build and maintain strong relationships with manufacturing engineering, material planning, and production, and to work and communicate across various levels of the organization. This position, under the direction of the Quality Assurance Manager, works closely with R&D, Design Assurance, Sustaining Engineering, and Manufacturing. This role will be integral in the development of new products and supporting day-to-day operations

Principal Responsibilities

•    Determine test requirements, test methods, sample sizes and statistical analysis for qualification/verification studies for manufacturing
•    Develop verification, validation and qualification plans and reports for manufacturing
•    Initiate and lead non-conformance investigations regarding component failures, finished goods failures, and product returns.  This includes but is not limited to performing risk analysis, determining root cause and recommending corrective action
•    Investigate customer complaints, including product/record investigation, health risk assessments, identification of CAPA’s and report generation
•    Lead root cause analysis and CAPA closure 
•    Leads efforts to qualify specification changes and qualify new test methods 
•    Coordinate the Change Impact Assessment activities 
•    Mentor, train and provide work direction to Quality Engineers and Quality Technicians
•    Participate in pre-design freeze quality activities
•    Proactively eliminates possible manufacturing process defects
•    Authors new SOPs and other documentation
•    Demonstrates a high level of proficiency in functional area
•    Define, plan and execute major projects related to product quality and regulatory compliance
•    Ensure company policies and procedures are followed, taking timely corrective action with the help of HR when necessary
 

Education / Experience Requirements

•    BA/BS in Engineering or physical sciences required
•    Eight (8) years of related experience required
 

Specialized Skills / Other Requirements

•    Demonstrates an in-depth understanding of functional area (process statistics, risk management, metrology and calibration, ISO13485, FDA QSRs, EU MDR)
•    In-depth understanding of the quality system and regulatory compliance
•    Critical thinker and active listener with good time management skills in order to work with staff and Project Management teams to define deliverables
•    Strong problem-solving skills
•    Ability to lead and provide direction through solid oral and written communication skills
•    Self-starter with the ability to quickly learn about new processes with very little information provided
•    Ability to write technical reports and presentations
•    Prior Product Quality experience in manufacturing and analytic approach to problem solving
•    Knowledge of quality related tools including, but not limited to, SPC, DOE and Quality Systems
•    Lean Six Sigma training (Certification preferred)

TRAVEL REQUIRED: 5 %