Mechanical Design Engineer in Medical Devices Quality Engineer 4-6yrs Pune
2d ago
source : Shine

Short Description

We are looking for Mechanical Design Engineer in Medical Devices Quality Engineer having 4-6yrs for Pune location


E / / ME /

Job ResponsibilitiesApply sound systematic problemsolving methodologies using defined business systems to identify prioritize communicate and resolve quality issues Coordinate NCs and CAPAs and drive the Nonconformance and CAPA metrics Monitor field performance complaints of recently launched and established medical devices against risk assessments Support post market surveillance of products through competent authority communication Act as an effective team member in supporting quality disciplines decisions and practices Update and maintain product risk management tools Hazard Analysis Fault Tree FMEAs Support medical device audits from internal or external authorities Support the project team for all document control activities Bachelors or higher degree in engineering with preference mechanical engineering 7to9plus years of experience in medical device quality engineering Professional training and certification in in Quality Management Systems including ISO 13485 Risk management ISO 14971 design assurance control verification and validation Sound understanding of medical device regulatory requirements for Class II and III medical devices Project planning resourcing timelines quality and budgets Skilled in implementing Quality tools like design of six sigma risk management FMEA FTA Fault Tree Analysis Preference for candidates with CQE certification or similar training and experience Proficient in project management tools like MS project,

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