Design Quality EngineerCollabera • Minneapolis, MN, US

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