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:

      Peterborough
    • State:

      NH
    • 03458
  • Assignment Type:

    Contract To Hire
  • Job Id:

    47442
  • Payrate:

    $45.00

Description

Davis Engineering is partnering with a great medical device company in northeast New Hampshire for an experienced Quality Engineer with medical device background on either a direct or contract-to-direct basis. If interested in this role, please apply with your Word formatted resume to this posting. To expedite the process, you can send your resume to Rich Gardner at rgardner@daviscos.com to be contacted more expediently. 

Sr. Quality Engineer

REPORTS TO:  Senior Director of Quality

 

DUTIES AND RESPONSIBILITIES:

  • Manages the Supplier Quality Program
    • Performs external surveys and audits on new and current suppliers and documents results of such visits.
    • Maintains the Approved Supplier List.
    • Compiles and issues Supplier Report Cards on Class “A” suppliers.
    • Calculates and publishes Supplier Quality Ratings.
    • Administers all Supplier Corrective Action Requests and verifies that supplier initiated corrective action was effective prior to SCAR closure.
    • Supplier validation review.  Review supplier generated validation documentation (for process and product).
    • Manages the Material Review Board and all associated activity.
  • Leads the Corrective Action/Preventive Action program for nonconformities related to Operations or suppliers.
  • Manages the inspection, measurement and test equipment calibration and maintenance program.
  • Responsible for designated product release from suppliers as needed.
  • Generates Standard Operating Procedures and Work Instructions as needed.
  • Directs employees involved in Receiving Inspection to assure quality control procedures are followed with regard to purchased products.
  • Investigates Quality issues arising from operations and manufacturing sites to identify root causes and recommend appropriate actions.
  • Analyze field returns, production data and other information to understand and correct design, manufacturing and user-related problems.
  • Participate in product Risk Analysis sessions and review verification/validation documentation upon request.
  • Develops inspection and testing methods and participates in the preparation of quality assurance plans, specifications and procedures.
  • Assist in product and process Corrective and Preventive Action (CAPA) investigations from identification and issuance through to implementation of solutions.  Monitor and assess actions for effectiveness and report results to management.  Conduct root cause analysis activities in order to understand and resolve product and process issues.
  • Active participation in the review of engineering specifications, protocols, and reports to assure that adequate quality assurance requirements are met, and designs are adequately transferred into manufacturing with high process capability measured against Critical to Quality Design Output Requirements.
  • Takes a leadership role in assuring all activities in the area of manufacturing equipment, processes and software validations meet FDA and International regulatory requirements.
  • Analyze field returns, production data and other information to understand and correct design, manufacturing and user-related problems.

 

 

QUALIFICATIONS                                                                                    

  • Five to Seven years of experience in medical device industry, with preference given to experience with products with electronic and software components.
  • Experienced with the application and implementation of GMP/QSR/ISO 13485/MDD/MDR and Canadian Medical Device regulations a plus.
  • Experience in addressing Corrective Actions in a regulated industry. Ability to investigate, understand, review and document complex design issues. Ability to effectively communicate technical findings and write technical reports of subject matter. Demonstrated competence in performing effective troubleshooting. Excellent problem-solving skills (root cause analysis).
  • Proficient with MS Office.
  • ASQ certification with active local membership is preferred. 
  • Ability to work on problems with limited direction.
  • Practical experience with FDA/ISO Safety standards for regulated medical devices.
  • Demonstrated knowledge of Quality Management System requirements in FDA regulated environments and understanding of ISO 13485 and applicable Medical Device Directives.

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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