Senior Quality Engineer

Senior Quality Engineer

s www.globalchannelmanagement.com jobopeningsjobs(at)globalchannelmanagement.co mSenior Quality Engineer needs 7 years of quality engineering experience in an FDA regulated medical device manufacturing environment. Senior Quality Engineer requires Advanced knowledge of and proficiency with medical device development life cycles and Design Control processes. Ability to handle complex issues and exercise judgement based on experience with minimal oversight from manager. Knowledge of QSR ISO 13485 and ISO 14971 Knowledge of IEC 62366 IEC 60601 Biocompatibility and Aging Studies preferred Ability to write Verification Validation protocols and reports. Problem solver. Six sigma green belt preferred. Competent using office software including MS Word Excel PowerPoint and Outlook. Senior Quality Engineer duties Implement new Usability Process Procedure and Templates and provide support to the transition to new Usability processes. Provide quality support for the Usability plan report and file. Implement Design Control process improvements to ensure a more effective efficient and compliant design control process. DHF Audits throughout the development process Development of Quality Plans Maintain and Manage the DHF after product commercial release Ensure that technical information is accurate and in compliance with international regulatory requirements. Perform all duties with minimal oversight required from direct manager.