Description
This position requires a BA/BS in Engineering or related discipline; a minimum 5+ years engineering experience with emphasis in supplier auditing, process/product qualification, quality assurance, and new product development for medical devices or equivalent combination of education and experience to perform at this level.Candidates for this position will need to understand design controls, on-going manufacturing controls, risk management, and regulatory and corporate compliance requirements.
Candidates considered appropriate will be those who have strong communication skills, solid knowledge of and experience with product and process qualification, and a solid understanding of design/process controls
Basic statistics, Minitab, SolidWorks, MS Project/PowerPoint/Excel and FileMaker/SAP skills preferred
Leadership and project management skills are desirable
Ability to work in a team environment required
Demonstrated application of Quality tools/methodologies, familiarity with Design Controls and other FDA/ISO requirements is essential
Sterilization, Nitinol, Elgiloy, precision metal processing (EDM and Electropolish) and tissue supplier experience is preferred
Regulatory compliance, quality system development and experience in the areas of medical devices is a plus
Lead Auditor Certification to ISO 13485 and/or FDA GMP preferred
To find out more about Real please visit www.realstaffing.com