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Quality Engineer

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MICRON PRODUCTS

2021-12-03 22:30:02

Job location Fitchburg, Massachusetts, United States

Job type: fulltime

Job industry: Engineering

Job description

Description:


I. JOB PURPOSE

Provide technical support and guidance to the organization through active involvement in developing inspection criteria and control plans, equipment suitability and calibration activities, equipment/test methodology, statistical analysis, product/ process validation, and manufacturing process and operations development activities.


II. KEY ACCOUNTABILITIES

Monitor quality objectives to confirm progress towards key goals and objectives.

Review any / all processes and procedures for improvement opportunities and assist in the implementation of improvements as needed.

Assist with the development of customer First Article Inspection (FAI) documentation and Incoming Inspection processes based on customer requirements. Monitor the effectiveness of these inspection activities and make changes as needed.

Assist with Process Failure Mode Effects Analysis (PFMEA's) documentation

Develop qualification/ validation plans and coordinate product/ process validations

Develop and implement statistical sampling plans based on customer requirements and operational needs

Manage equipment calibration program

Determine equipment suitability

Perform supplier audits and work with suppliers to resolve supplier issues

Assist with customer complaint investigations and support corrective and preventive action process as applicable

. Requirements:

  • Minimum of 5 years in Quality Assurance position in a regulated (ISO 13485 / AS9100 / QSR) manufacturing environment.
  • Bachelor of Science - Mechanical Engineering preferred or equivalent work experience
  • Experience in reviewing and reading product engineering drawings for complex mechanical assemblies.
  • Working knowledge of metrology equipment, calibration management, auditing, and statistical analysis.
  • Strong facilitation and communication skills
  • Process mapping experience
  • Ability to work independently and strong process control background
  • Familiarity with product/ process validations


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