Quality Engineer II

The position is responsible for providing quality engineering support to both production processes as well as new product development addition QE is responsible for assisting in the development maintenance and improvement of the manufacturing plants 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.

• 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.

Required:

• This position requires a Bachelors of Science in Mechanical Industrial or similar engineering degrees or Quality Certifications are also desirable: CQE CQA CQMgr. Six Sigma or Lean.
• This position requires5-10yearsin aManufacturingEngineeringor Quality/Continuous Improvement 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