1970-01-01Davis Companieshttp://www.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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  • 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.
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Quality Engineer

  • Specialty:

    Engineering
  • Title:

    Quality Engineer
    • City:

      St. Paul
    • State:

      MN
    • Zip Code:

      55121
  • Start date:

    11-04-2020
  • Status:

    Closed
  • Assignment Type:

    Direct Hire
  • Job Id:

    55358

Description

DAVIS Companies has partnered with a leader in Medical Device manufacturing to identify a Quality Engineer to join their team! 

 This position will be involved in processing complaints, CAPA’s, document changes, maintaining the calibration system, performing audits and maintaining technical files.

RESPONSIBILITIES OF THE QUALITY ENGINEER: 

  • Follow all regulations, standards, procedures and work instructions defined in the Quality System Manual
  • Maintain the Complaint system, including documenting, reviewing, investigating and closing Complaints
  • Review, investigate and document CAPAs
  • Update or create procedures, work instructions, forms and labels using Word, Excel, Label View, etc.
  • Review and release sterile product
  • Review document changes
  • Support the compilation of technical files including clinical evaluation reports, essential requirements, usability engineering reports & risk management files
  • Perform internal, supplier and design history file audit
  • Assign and review deviations
  • Support agency listings and annual registrations
  • Support inspections and audits performed by FDA, Notified Body, OSHA, etc.
  • Support / Lead Customer audits
  • Assist in compiling Design History Files

EDUCATION & EXPERIENCE REQUIREMENTS OF THE QUALITY ENGINEER: 

  • Bachelor’s Degree preferred and a minimum of 3 years medical device experience OR minimum of 5 years’ experience in medical device industry acceptable
  • Software proficiency: Microsoft Word, Microsoft Excel, Adobe Acrobat, LabelView, BarTender
  • Good understanding of FDA 21 CFR Regulations, ISO 13485, Health Canada Regulations, European Medical Device Regulations, Good Documentation Practices, ISO 14971

#MON
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