Design Quality Engineer

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Design Quality Engineer

• Plymouth, MN
• Contract

Company Description

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;

Gaurav Sahai

630-315-7387

gaurav.asahai(at)collabera.com

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Design Quality Engineer

• Plymouth, MN
• Contract