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 as required.
Assist Project Manager in reviews and ensure project complies with QA processes and adhering to defined timelines.
Review changes to existing process and products and drive them via change control and ensure timely completion/closure.
Work with global team, co-ordinate with different stakeholders (PDO, QA, RA, etc) to understand their requirements, prioritize the tasks & ensure completion.
Participate as well as lead the meetings with cross functional team to communicate priorities, requirements, key issues/risks and ensure they are completely understood and set clear expectations.
Independently drive the change controls.
Resolve queries, concerns (as needed) & drive the project to completion.
What You’ll Bring
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. Should be able to communicate effectively in a multi-cultural working environment.
Strong collaboration and interpersonal skills.
Ability to co-ordinate with stakeholders of cross functional and Leadership Team.
Excellent critical thinking and problem-solving skills and application of methods and tools.
Independent worker as well as Team Player with strong execution abilities to complete projects within timeline.
Knowledge of (U.S.) & EU Regulations and medical device standards – ISO 13485, ISO 14971.
Good to have experience in Change Management process and tools.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
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