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Quality Engineer


Requisition Number: P12231

Region: US
State: Massachusetts
City: Clinton

Responsibilities

  • Experienced Quality Engineer needed for our engineering/manufacturing medical device facility in Clinton, MA!
  • 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. 
  • Some programs may have vision requirements

Qualifications - Education & Experience

  • Bachelors degree in an engineering discipline or equivalent experience,
  • Minimum six (6) years quality/regulatory experience
  • Minimum Three (3) years auditing experience

Qualifications - Skills & Competencies

  • Understanding of the project development process, associated terminology, and quality system requirements
  • Ability to effectively present information and respond to questions from group of managers, sales, and customers
  • Strong communication (verbal and written), teamwork and organizational skills
  • Ability to identify problems, and develop and implement actions to resolve them
  • Ability to motivate and influence people to achieve customer satisfaction
  • Demonstrable track record of project accomplishment
  • Demonstrable track record of planning activities with contingency actions

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