Sr. Quality Engineer

Position Summary

The Sr. Quality Engineer is responsible for improving 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 and production in order to work and communicate across various levels of the organization. This position works closely with Design Assurance, Sustaining Engineering, and Manufacturing. The role is integral in 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.
•    Support investigation of customer complaints, including product/record investigation, health risk assessments, identification of CAPA’s and report generation.
•    Coordinate the Change Impact Assessment activities. 
•    Support site initiatives such as Cost of Quality, Defects Per Million, and Continuous Improvement Projects.
•    Mentor and train engineers and production team members.
•    Reduce manufacturing process defects through corrections implemented.
•    Revise simple updates to manufacturing or quality SOPs and other related documentation.
•    Ensure company policies and procedures are followed.
•    Establish and maintain effective working relationships with fellow employees. 
•    Proactively eliminates possible manufacturing process defects.
•    Demonstrate 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

•    Bachelor’s degree in a Science or Engineering discipline. 
•    5 years of Quality Engineering work experience required. 
•    Experience in a manufacturing environment, with preference in a regulated or medical devices industry
 

Specialized Skills / Other Requirements

•    Demonstrate 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
 

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