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, in-process 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
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 cross-functional / 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
Understanding of the concepts of PPAP, APQP, MSA, SPC, FMEA, Risk Management, Process Capability, Complaint Handling, Supplier assessment & control, Data analysis, Measurement systems, Pro-
E, understanding of Design system and ability to read Design prints.
Work From Home : NoTravel Percentage : None