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.

• 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

• 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;