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:

      Framingham
    • State:

      MA
    • 01701-
  • Assignment Type:

    Direct Hire
  • Job Id:

    45257
  • Payrate:

    $49.52

Description

Quality Engineer

We are looking for a Quality Engineer with prior Medical Device experience to join a team of 10 engineers working toward delivering a brand new medical device over the next 2 years You will be leading the Quality organization for pilot manufacturing quality initiatives and limited post market activity, as well as playing a role in design assurance. . 

Responsibilities

  • Review, create and edit technical files and design control documents for medical devices with integrated hardware and software in accordance with QMS system and applicable regulations
  • Work with contract manufacturers to ensure quality standards are met.
  • Prepare and review design verification test protocols, procedures and reports
  • Drive risk management file activities and updates inclusive of hazard analysis and DFMEAs and the inform risk management approach for engineering
  • Assist engineering in the compilation of design history files in accordance with ISO 13485, ISO14971 Risk Management and IEC 60601 or other applicable USFDA and EUMDD regulations
  • Support potential ISO 13485 certification, CAPAs and audits (internal and external)

Qualifications

  • BS in Engineering, Bioengineering with at least 5 years of experience working with medical device design FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
  • Experience in product & process development
  • Proficient with medical device product and process risk management

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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