Advance Quality Engineer
SGTC India
3d ago
source :

Job Description Roles and Responsibilities Primarily responsible for Risk management Risk Table creation Analysis FMEAs Quality Plan Literature Review Device Master Record Quality Training Plan and Technical File Product risk assessment as per ISO14971 Primary participant in new supplier selection validation and contract development Assists vendors in resolving manufacturing and quality issues as required Partners with the operations team to develop and maintain a robust internal and external supply chain Contribution examples include the performance of supplier audits risk assessment mitigation and coaching Develop procedures for incoming inprocess and final inspections for new product development Assists and mentors the unit quality engineer in the trending and analysis of quality data e g complaints Tech Support trouble tickets Pareto charts scrap warranty return rate etc and provides guidance to address issues as appropriate Authors and reviews procedures to ensure GMP and ISO 13485 compliance Lead product quality related projects Supports the business in addressing and solving quality problems Conduct internal audits participate in corporate and FDA audits Support process validation programs for new product development Work with crossfunctional cross cultural teams to develop regulatory guidelines and procedures Provide inputs for NPDP for adherence to QMS and Good Documentation practices Work with engineering manufacturing teams to develop robust verification test strategies to ensure product safety and reliability Must have delivered multiple projects in AQE function and understand Risk Management processes in depth Supervisory Responsibility Will supervise the project deliverables from Quality deliverables standpoint Will act as mentor to Quality Engineers Technical Skill Set

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