Advance Quality Engineer - Mechanical (3-7 yrs)
Job description :
- 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 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 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.
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