Quality Engineer II

Position Summary

The position is responsible for providing quality engineering support to both production processes as well as new product development teams.  In addition, QE is responsible for assisting in the development, maintenance and improvement of the manufacturing plant’s overall quality system in accordance with the requirements of ISO, FDA QSR and STERIS policies.  Major responsibilities of the role would include but  not be limited to: improvement in key quality metrics, leading improvement projects including data analysis, maintaining the Quality System and manufacturing process integrity and following the New Product Development (NPD) process to ensure that the team meets key quality deliverables and targets.  

What You'll Do as a Quality Engineer II

• Maintain company compliance of FDA Quality System Regulations and ISO 13485 standards.  
• Serve as a team member to provide quality engineering expertise to continuous improvement teams and manufacturing support. 
• Plans and directs activities concerned with development, application, and maintenance of quality standards for industrial processes, materials, and products: 
• Develops and initiates standards and methods for inspection, testing, and evaluation, utilizing knowledge in engineering fields such as chemical, electrical, or mechanical.  
• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.  
• Establishes program to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities. Develops and implements methods and procedures for disposition of discrepant material and devises methods to assess cost and responsibility.  
• Directs workers engaged in measuring and testing product and tabulating data concerning materials, product, or process quality and reliability.  
• Compiles and writes training material and conducts training sessions on quality control activities. 
• May specialize in areas of quality control engineering, such as design, incoming material, process control, product evaluation, product reliability, inventory control, metrology, automated testing, software, research and development, and administrative application.  
• Perform all other duties as assigned. 

The Experience, Skills, and Abilities Needed

Required:

• This position requires a Bachelor's of Science in Mechanical, Industrial or similar engineering field.  Advanced degrees or Quality Certifications are also desirable:  CQE, CQA, CQMgr., Six Sigma or Lean. 
• This position requires 5-10 years in a Manufacturing, Engineering or Quality/Continuous Improvement environment.  Previous Quality Systems Experience  
• Excellent problem solving skills including FMEA or root cause analysis and implementation of Corrective and Preventive Actions.

Preferred:

• Knowledge of basic statistical and engineering principals

• Leadership ability to manage projects in a cross-functional team environment

• Demonstrated effective organizational, oral and written communications skills 

• Medical Device experience and familiarity with ISO and QSR/GMP regulations 

• Must be flexible in working overtime as necessary

• Computer skills and experience with applications such as EXCEL, Minitab, Word