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Design Quality Engineer
Design Quality EngineerCollabera • Minneapolis, MN, US
Design Quality Engineer

Design Quality Engineer

Collabera • Minneapolis, MN, US
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Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.

Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.

Job Description

Knowledge / Skills / Abilities

  • Extensive knowledge of quality tools
  • Risk analysis
  • Highly proficient in math and use of statistical techniques
  • Root cause analysis
  • Problem solving approaches
  • Reading and correcting drawings
  • Computer literate; use of word processing, spreadsheets
  • Project management methods and tools
  • Quality System Regulation (QSR)
  • Medical Device Directives (MDD)
  • ISO procedures / Other Nation & International Standards
  • FDA requirements and guidance
  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • Knowledge of sampling methods
  • Recognize problems and proactively take corrective measures

Qualifications

Professional Experience :

  • Actively represent Quality Assurance function on CAPA teams
  • 5+ years experience in Quality Engineering in the medical device industry (or related industry).
  • Familiar with critical elements of the design history file including risk management, design verification and validation tests and ensuring compliance of these elements to procedural requirements.
  • Experience in related engineering areas, e.g. R&D or Manufacturing may also be applicable if experience includes work responsibilities listed above.
  • Advanced degrees may be used reduce required experience.
  • Experience in vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and / or guide wires preferred.
  • Self-motivated and committed to a team approach
  • Strong interpersonal, organizational and project management skills
  • Strong oral, presentation and technical writing skills
  • ASQ certification in Quality Engineering areas desirable
  • Demonstrated skills in decision making – preferably across a broad spectrum of Quality Engineering
  • Education

  • Bachelor's Degree or higher in Science or Engineering (or related field)
  • Additional Information

    To know more on this position or to schedule an interview, please contact after applying here;

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    Quality Engineer • Minneapolis, MN, US