I am recruiting a Senior Manufacturing Engineer to work on a remediation project in Co. Limerick
Responsibilities
* Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards.
* Validate and implement medical device manufacturing processes as assigned.
* Identify equipment/fixture installation qualification requirements.
* Characterization of processes and their outputs/acceptance criteria.
* Written preparation of applicable validation reports that meet regulatory/company standards.
* Verification testing.
* Project management.
* Maintain accurate and timely reports and records.
* Must have excellent analytical and problem solving skills.
* Positive attitude, strong work ethic and self-motivated. Ability to handle multiple projects simultaneously and work with minimal supervision.
* Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
* Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and Quality Management System where applicable.
* Delegate for Manufacturing Engineering Manager and the Senior Test Engineer.
Qualifications
* Bachelor’s degree is desired, preferably in engineering or a related field and / or relevant experience.
* Minimum of 5 years’ Validation/relevant experience is required.
* Strong interpersonal and organisational skills and the ability to communicate at all levels of the organisation.
* Willingness to seek out and drive improvement.
* Proven project planning skills and the ability to execute projects in a timely and effective manner.
* Team Player with ability to develop strong working relationships.
* Demonstrated problem solving skills. Highly motivated individual, self-starter with a passion for excellence.
* Must be able to work in a fast-paced environment.
* Excellent attention to detail.
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