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This individual will be part of and provide support to the Support to Sustaining Engineering team. In this role the individual will be part of the SPO team that leads the efforts in Change Management and related activities.
Job Responsibility:
Initiate, plan and complete small or complex project through monitoring, tracking and analyzing project activities and metrics
Serve as SPOC for team and collaborate with Project stakeholders
Handling of Change controls/Change Management activities
Ensure implementation of quality processes including Change control and design control activities
Preparation and review of project related documents, protocols and reports
Assist Project Manager in reviews and ensure project complies with QA processes
Review Changes to existing process and products and drive them via change control
Work with Global team, Co-ordinate with different stakeholders (PDO, QA, RA, etc)
Participate as well as Lead the meetings with cross functional team
Independently drive the change controls
Resolve queries, concerns & drive the project to completion
Requirements:
Bachelor's or Master's degree in Bio Medical /Mechanical Engineering or Equivalent with 3+ years of experience in Sustaining Engineering projects
Excellent Verbal and Written skills in English
Excellent communication and presentation skill
Strong Collaboration and interpersonal skills
Ability to co-ordinate with stakeholders of cross functional and Leadership Team
Excellent critical thinking and problem-solving skills
Independent worker as well as Team Player
Knowledge of US & EU Regulations and medical device standards – ISO 13485, ISO 14971