Design Quality Engineer

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