Quality Engineer

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Quality Engineer

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  • Title:

    Quality Engineer
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  • Start date:

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  • Assignment Type:

    Direct Hire
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Our client located in Franklin, Ma is looking for a Quality Engineer to join their team on a direct hire basis. 

The qualified candidate should be able to use Quality & Process Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision.

Primary Responsibilities:

  • The individual must be capable of working independently and in a team setting supporting the Quality and Operations groups. 
  • Investigate and resolve work-in-process problems to reduce/eliminate scrap and rework
  • Analyze process statistics and conduct efficiency studies
  • Recommend and implement process improvements and modifications
  • Establish production/process standards
  • Supports on-site transfer projects and product scale-up activities.
  • Optimizes manufacturing processes to provide sustainable gains in cost effectiveness and product performance through statistical analysis, designed experiments, and procedural changes.
  • Drive quality improvements by increasing internal competencies in process control / verification and validation studies, root cause analysis, failure mode and effects analysis (FMEA), and the use of Process Excellence tools.
  • Works with suppliers, customers and participates in multi-functional teams to resolve technical/quality issues and develop new protocols.
  • Partner with Operations to assure alignment of goals, objectives and strategies.
  • Provide general engineering support to in-process inspection & in-coming inspection.
  • Implement quality and efficiency improvements in in-process inspection.
  • Evaluates process critical quality parameters and updates specifications and protocols.
  • Additional duties and responsibilities as required.

Level of Skill, Education and Experience:

  • A minimum B.S. in an engineering discipline preferably mechanical engineering.
  • 0-5 years experience.
  • Strong engineering skills, problem analysis/solving.
  • Excellent written and oral communication skills. Understanding of GMP, FDA and SOP standards, guidelines, and regulatory requirements.
  • Ability to work in a fast paced manufacturing environment while managing multiple projects.

Strong engineering skills with working knowledge of the following:

  • Process validation and verification activities. (IQ, OQ, PQ, PPQ).
  • Risk analysis techniques, which include PFMEA (Process Failure Modes and Effects Analysis). Manufacturing Control Plans and Flow Plans.
  • Blue print & GD&T reading. Problem solving techniques including root cause analysis, and cause and effect analysis.
  • Proficiency with Microsoft Office products (Word, Excel, Project, PowerPoint) and Minitab.
  • Experience in the Medical device is highly desired. Hands-on experience in the manufacturing, quality & process disciplines.

#MON #marle-b

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