Quality Validation Engineering Manager Job in Springfield, Massachusetts US

Our client, a world-class manufacturer recognized for their innovative technologies and engineering capabilities, is seeking a self-motivated, practiced Validation Engineering Manager with strong analytical and problem solving skills to provide engineering support in validation process development.  If you are a bright Quality or Validation Engineer ready for your next career step and have solid experience in the medical device market, then this is the perfect opportunity for you!

 

Position Summary:

·         Provide leadership over validation systems and document control.

·         Set goals, prioritize tasks and direct personnel to execute initiatives necessary to achieve goals

·         Work with manufacturing to develop, coordinate, and implement technical instruction and direction.

·         Work closely with customers, suppliers and liaise with the Global Tooling and Program Management teams to deliver solutions which enhance quality, delivery, performance, and profitability.

·         Develop, communicate and manage accountability of site validation initiatives and priorities.

·         Manages complex validation projects; Develops protocols, determines test plan and executes validations

·         Responsible for workflow, production, training for new employees, and answering job-related questions

·         Use proper tools for monitoring manufacturing operation to determine root causes from scrap, downtime, etc. and to recommend solutions (process maps, SPC, process capability, trending, etc.)

·         Develop/revise specifications, STM’s, calibration procedures and SOP’s

·         Develop new test methods and conduct proper statistical analysis to demonstrate their reliability

·         Evaluate and document corrective actions, deviations and material dispositions in support of the Quality department

·         Prepare and process documentation to include specification changes, change request forms, validation documents, deviations and standard operating procedures.

·         Ensure compliance, continuous improvement and annual revalidation of clean rooms per ISO standard

 

Qualifications:

 

·         Bachelor of Science degree in engineering

·         Five years of experience in a complex manufacturing environment, injection molding experience a plus

·         Knowledgeable in Good Manufacturing Practices (GMP), medical device or pharmaceutical regulated

·         Project management competence plus ability to manage multiple activities and work independently

·         Prior demonstrated managerial/leadership experience in Quality organization a plus

·         6-sigma training with demonstrated application experience is a plus

·         Proficiency with MS Windows along with solid working knowledge of Mini-Tab or equivalent programs

 

This company’s success is due to their drive to launch new products and continuously improve their current processes. This opportunity will keep you sharp and excited.  If you possess the drive and related knowledge and are seeking a fresh challenge, apply today! Contact Marty Holmes, President, Management Search, Inc., 413-233-5483.

 

 

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