We are seeking a highly skilled and dynamic engineer to fill a key role in our organization.
Job Responsibilities
* Develop and execute comprehensive documentation for equipment and systems, encompassing functional specifications, software design specifications, calibration specifications, and related documentation.
* Collaborate with cross-functional teams to create and implement validation protocols, including IQ/OQ/PQ, Test Method Validations, and Test Method development.
* Maintain control over software assets and ensure adherence to validation procedure guidelines.
* Ensure Quality Policy and Quality system procedures are upheld by promptly reporting noncompliance issues to management.
* Work collaboratively with the Quality department to guarantee all validations align with industry standards.
* Cultivate effective relationships with stakeholders through collaboration on project deliverables.
* Monitor project schedules and scope changes to ensure timely delivery of project requirements.
Requirements
* A Bachelor's degree in Life Science, Engineering, or a closely related field is mandatory.
* Previous experience in Research & Development within the medical device industry is desirable.
* A minimum of 3-4 years of Equipment and CSV experience within the medical device industry is required.
* Excellent communication, team, and organizational skills are essential.
* The ability to work independently and proactively manage assigned tasks to meet deadlines is necessary.
* The capacity to establish and maintain positive working relationships with colleagues is crucial.