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Quality Engineer


Requisition Number: P11541

Region: US
State: Massachusetts
City: Clinton

Responsibilities

  • Be a technical resource for the initiation and implementation of cost improvement plans on new and existing programs
  • Coordinate new process techniques that improve overall job efficiencies
  • Implement systems and procedures that assure compliance with Quality Standards
  • Development and implementation of statistical incoming and in-process sampling/control plans
  • Manage the qualification of processes performed by PPC suppliers; troubleshoot and lead corrective actions relating to supplier performance; improve process for supplier data submission to reduce internal inspections
  • Participate in AQP meetings representing quality, where appropriate
  • Provide engineering team with information and analysis tools as needed
  • Facilitate communication between engineering function, manufacturing, and quality
  • Responsible for being a communication liaison between the customer and manufacturing facility
  • Leads investigation of out of specification situations to determine if there is impact to released product.  Responsible for writing technical reports in support of NCMR investigations, CAPAs and containment activities used to support recall or no recall decisions.
  • Use statistics to assess product performance data, solve complex manufacturing quality problems and support validation strategies (Cpk, SPC, t-tests, OC Curves, sample size determination, Minitab).
  • Participate in initial process development, Design for Manufacturing and Design for Assembly phases.
  • Reviews, analyzes and details on quality issues related to manufacturing process and or customer design.
  • Interfaces with engineering, operations, customer, and vendor representatives to ensure all requirements are met.
  • Develops validation templates.
  • Perform External Audits as needed.
  • Assist with third party and FDA quality audits as needed.
  • Responsible for leading change control teams to ensure changes to processes and equipment do not impact product quality or the validated state. 

Qualifications - Education & Experience

  • B.S. degree in engineering field with 2-5 years related experience,
  • Strong technical skills in injection molding, tooling, materials, product design, and affiliated processes; to include secondary operations and automation

Qualifications - Skills & Competencies

  • Ability to manage multiple small- to medium-scale projects/programs
  • Strong communication, teamwork and organizational skills
  • Ability to understand and implement customer requirements
  • Ability to develop and meet project schedules
  • Ability meet financial goals
  • Ability to work with sales to identify and develop future account needs
  • Understanding of PPC’s technologies (benefits, when to use, etc)

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