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Quality Assurance Engineer/Medical Device

Eingestellt von Software Specialists

Gesuchte Skills: Engineering, Support, Engineer



The Quality Assurance Engineer is responsible for providing engineering process support in accordance with documented procedures and practices. The QA Engineer is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices.


Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.
Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.


Bachelor's Degree in an engineering or technical discipline (or non-technical degree with 5 years of experience in manufacturing, engineering or quality assurance experience in addition to any other experience requirements).
Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR and ISO 13485.
Demonstrated understanding of product development life cycles, design change and document change control, process verification and validation methodologies, manufacturing/production process control methodologies, and servicing in a medical device environment.

NOTE FROM THE MANAGER - Our department is focused on new product development and I need people well versed in design controls of hardware and software type medical devices. Please see the attached job description. Focus on experienced degreed candidates having experience with Medical Device design and QMS documentation experience. This group provides quality support for 62 active running programs. The qualified candidate will review and approve quality related documentation for the release of products. They will need to have great attention to detail to support document review and good documentation practices. Must have experience supporting both Hardware and software products, no Pharma... ASQ is preferred.


  • Einsatzort:

    Wisconsin, Vereinigte Staaten

  • Projektbeginn:


  • Projektdauer:

    Keine Angabe

  • Vertragsart:


  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Software Specialists

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