Description
Responsibilities:Provide guidance for: Market Specification, Functional Specification, Design Verification and Validation, Test Method Validation, dFMEA and pFMEA, and Design Reviews.
Provides sustaining engineering to support post market design changes, including assessment of proposed changes using design control methods.
Identifies the opportunities for continuous improvement of the Quality Systems, including the design control, document generation, and design testing processes.
Manages, supervises and provides direction to quality engineers on professional, personnel issues, and provides development opportunities.
Work well in a team environment as a leader and a contributor
Provides guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.
Requirements:
Hands on experieince with Design Control in the IVD or Medical Device industry.
Ability to make major changes to Qualiy Systems including influencing change to maximize business results.
Experience managing and implement multiple large projects with little no no supervision.
Ability to influence & negotiate with people & resolve issues.
Ability to identify customer needs & issues & develop realistic solutions to meet needs & solve problems.
Ability to communicate recommendation and decisions across a wide spectrum of the organization.
B.S. Engineering or similar field
8+ years industry experience
ASQ certification is a plus.
To find out more about Real please visit www.realstaffing.com