Design Quality Engineer

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. 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 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) 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