Quality Engineer

1970-01-01Davis Companieshttp://daviscos.com/wp-content/themes/davis_theme/assets/images/logo.svg325 Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]
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Quality Engineer

  • Specialty:

    Engineering
    • City:

      Laconia
    • State:

      NH
    • 03246
  • Assignment Type:

    Contract To Hire
  • Job Id:

    47007

Description

Our client located in Laconia, NH is looking for a Quality Engineer to join their team on a contract  to hire basis. 

Position Requirements:

  • Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards. 
  • Actively participates in internal audits, management review and other activities covered under Quality Manual, Policies and Procedures
  • Provide customer related quality and regulatory inquiries support
  • Compiles and writes training material and conducts training sessions on quality control activities
  • Provide QE direction, analysis and recommendations for Product Development to successfully launch new products into active production in a timely and cost effective manner. Directs development and maintenance of internal/external standards relative to Design and Development,
  • Lead implementation of continuous improvement projects or act as subject matter expert for SPC, FMEA, DOE and process validation.
  • Lead and provide Project Management support as needed
  • Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields
  • Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data
  • Performs measurement system analyses to evaluate test and inspection equipment
  • Leads disposition of discrepant material and devises process to assess product quality and reliability
  • Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration
  • Lead supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier’s methods, supplier audits, management of supplier corrective and preventative actions and assist in FMEA
  • Direct support for FDA and ISO inspections and registration
  • Support and Participate in Continuous Improvement activities
  • Support and Participate in activities that increase the ratio of value added  to non-value added processes
  • Demonstrates leadership through mentoring of junior staff and responsiveness to business needs to achieve positive results
  • Demonstrates technical ability through the application of engineering skills, approaches and knowledge

 

Qualifications:

  • 3-8 years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility
  • Experience with FDA and ISO 13485 Certification inspections is a plus
  • 3 plus years Project Management experience, supervising diverse teams
  • Must be adept in use of computer software for the analysis of data, preferably Microsoft Excel and statistical packages (Minitab preferred)
  • Quality Engineering certification (CQE) preferred or equivalent body of knowledge in areas which include, but are not limited to Statistics, SPC, Geometric Dimensioning/Tolerancing; Sampling, Design of Experiments, etc. Ability to analyze, understand and effectively communicate this technical material. Experience with Lean Manufacturing and Six Sigma is a plus
  • Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision
  • Must possess excellent verbal & written communication skills, which include but are not limited to presentation, organizational and management skills

Quick Apply

  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
  • Accepted file types: pdf, doc, docx, txt, rtf.
  • By applying to this position and providing my contact information, I give The DAVIS Companies permission to provide me with email communications and information.

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