Sr. Quality Engineer

May 9, 2022

Sr. Quality Engineer

Cold Chain Technologies
Published
May 9, 2022
Location
Franklin, Massachusetts
Category
Quality  
Job Type

Description

The Sr. Quality Engineer is responsible to perform quality engineering duties including, manufacturing support, quality monitoring, problem solving, process improvement, CAPA management and internal/external auditing. Knowledge of commonly used concepts practices and procedures within the field are required. The position relies on training, experience and judgment to plan and accomplish goals. A certain degree of creativity and latitude is required while performing a variety of complex tasks.

Responsibilities:

  • Drive the identification, implementation, and use of statistical methods throughout the plant. Statistical methods include Statistical Process Control (SPC), Designed Experimentation (DoE), and acceptance sampling among others.
  • Establish, monitor, analyze, and report on the major quality indicators for the plant. Utilize accepted capability indicators (CP, CpK, PPM, etc.).
  • Create and facilitate problem-solving teams; including the use of problem solving tools such as FMEA.
  • Investigate, analyze, develop and determine processes and process improvements on existing products to improve quality and or productivity.
  • Develop and implement quality tools in the line such as defect tracking, random audits, verification check sheets, etc.
  • Assist establishing, implementing, and maintaining the quality management system.
  • Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.
  • Plan and implement projects to improve quality control and monitor internal quality.
  • Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
  • Analyze failure, corrective and preventive action to respond to customer complaints.
  • Interface with external customers and suppliers on quality-related issues.
  • Create and maintain company quality documentation, such as quality manuals, quality procedures, etc.
  • Continuously improving QA receiving inspection process and procedures.
  • Ensure timely resolution of supplier failure, corrective actions and preventive actions.
  • Manage suppliers’ performance and conduct audits.
  • Perform duties in accordance with established quality standards.
  • Actively support Health, Safety and Environment rules and regulations.
  • All other duties and responsibilities as assigned

Requirements:

  • BS in Manufacturing or Industrial Engineering.
  • Min 5+ years of experience in manufacturing quality environment.
  • Working knowledge of ISO 9001:2015.
  • ASQ Certified Quality Engineer or Certified Quality Auditor preferred.
  • Six sigma green / black belt certified and Lean Manufacturing experience.
  • Experience in a cGMP and FDA regulated environment preferred.
  • Quality systems auditing experience; preferably as a lead auditor.
  • Experience in MRB, design reviews, supplier audits, corrective action programs.
  • Thorough understanding of QA standards, implementation and auditing.
  • Thorough understanding of statistical techniques and analyses.
  • Strong knowledge and use of MS Office applications, integrated MRP database applications, and experience with Minitab also desired.
  • Excellent verbal and written communication skills.
  • Experience in driving improvement initiatives.
  • Ability to integrate and work well in a team environment.
  • Effectively manage multiple and changing priorities.
  • Ability to work in a fast-paced environment.
  • Ability to lift 50 lbs. on occasion.
  • Occasional travel required.
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