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Quality Design Engineer - Medical Device

Company: Kelly Services
Location: San Clemente
Posted on: September 21, 2019

Job Description:

Kelly Services-- has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary opportunity to work as a Design Quality Engineer at a prestigious Fortune 500-- company working in San Clemente, CA.

This is an 8-month temporary position at 40 hours per week.

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the "submit now" button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position (keig126@kellyservices.com) however your resume must be received via the "submit now" button included within.

Job Description:

The Quality Engineer will support the Design Quality Engineering Department and report to the Quality Engineering Manager. The Quality Engineer is responsible for supporting Design validations and verification through adherence to design control and good documentation practice requirements.

Responsibilities:



  • Gather and initiate main documents of DHF

  • Design Input, Design Output, Design V&V and Design changes

  • Support R D in collecting data of Remediation project

  • Work on accelerated shelf life sterility studies, initiating testing protocols/reports

  • Create and edit Design documents supporting technical Assessment, testing reports and Regulatory submission

  • Support/Lead Risk Assessment DFMEA and PFMEA

  • Build productive relationships internally and externally

  • Work with R&D, Quality Engineers and Manufacturing Engineers on qualification of new or modified

  • Design and Process Support initiatives for continuous quality improvements

    Skills:



    • Knowledge of the Medical Device Industry and familiarity with ISO and FDA QSR Regulations

    • Six-Sigma Methodology DOE, Process Capability, Gage R&R, etc. is preferred

    • High Technical writing competency

      Education and Experience:



      • Bachelor's degree in Engineering or Technology

      • 2-3 years' experience in the Medical Device or Engineering Industry

      • Work is performed in a clean room environment

      • While performing the duties of this job, the employee may be required to sit or stand for long periods of time

      • Must be able to occasionally move and lift objects of up to 25 lbs.


        Why Kelly--?Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.About Kelly--At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

        Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Keywords: Kelly Services, Lancaster , Quality Design Engineer - Medical Device, Healthcare , San Clemente, California

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