Design Quality Engineer

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