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Quality Engineer

Milford, Massachusetts
Job Type
13 Sep 2020

The individual must be capable of working independently and in a team setting supporting the Franklin Quality and operations groups. Major responsibilities include:

  • 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
  • Implement real-time Statistical Process Control
  • Support on-site transfer projects and product scale-up activities.
  • Optimize 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 effect analysis (FMEA) and Process Excellence tools.
  • Work 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 & incoming 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.

Job Requirements:
  • A minimum B.S. in an engineering discipline preferably mechanical engineering with 0-5 years of 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.
  • Supplier quality experience highly desired.
  • 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
    • Blueprint & 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 medical device is highly desired.
  • Hands-on experience in the manufacturing, quality and process disciplines.
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  • Job Reference: 173885257-2
  • Date Posted: 13 September 2020
  • Recruiter: John Galt Staffing Inc.
  • Location: Milford, Massachusetts
  • Salary: On Application
  • Sector: Engineering
  • Job Type: Permanent