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Quality Process Engineer

1 month ago

Manchester, New Hampshire, United States Merrimack Manufacturing Full time
Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life. Merrimack Manufacturing has an exciting position for a Quality Process Engineer . How you will make an impact: As a member of the Quality team, the Quality Process Engineer focuses on ensuring the quality and efficiency of manufacturing processes by developing and implementing quality control measures, analyzing data, and identifying areas for improvement.
  • Evaluate existing production processes, identify potential issues, and develop strategies to improve quality and efficiency.
  • Implement and maintain quality control processes, ensuring that products meet specified standards and requirements.
  • Collect, analyze, and interpret data related to production processes and quality performance, using statistical tools and techniques.
  • Investigate and resolve quality issues, identifying root causes and implementing corrective actions.
  • Create and maintain documentation related to quality procedures, standards, and training materials.
  • Work closely with other departments, such as manufacturing, engineering, and quality assurance, to ensure that quality is integrated into all aspects of the production process.
  • Support ongoing efforts to improve processes and systems, seeking ways to reduce defects, improve efficiency, and enhance customer satisfaction.
  • Ensure that processes and products comply with relevant industry standards and regulations.
  • Investigate any problems that arise during production to determine the cause and implement corrective actions.
Duties & Responsibilities:
  • Working under the direction of the Quality Manager, ensure all product, processes, and components are within specifications.
  • This position may also serve as a member on collaborative cross-functional teams, to support new product development efforts, commercial production, material-related design changes, and manufacturing and process changes, risk management activities, and other compliance projects.
  • Work in compliance with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016.
  • Lead nonconformance reports (NCR) and CAPA investigations.
  • Lead manufacturing and quality system improvements.
  • Lead customer feedback process and investigations.
  • Author Change Orders (CO) to drive procedure and process changes; support CO implementation tasks.
  • Use experience with engineering and technology to ensure compliance with applicable standards and regulations.
Education and Experience:
  • Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering or equivalent, or Associates with equivalent experience.
  • 3 to 5+ years' experience in an ISO9001, AS9100, or ISO13485 manufacturing environment
  • Performing statistical data analysis using Minitab or equivalent.
  • Presenting and leading meetings with an audience of peers and senior management level.
  • Knowledge and comprehensive understanding of CAPAs, root cause analysis, and the 8D method.
  • Excellent interpersonal, verbal and written communication skills
  • High level of attention to detail and accuracy.
  • Ability to manage multiple priorities daily
Merrimack Manufacturing