Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of ground-breaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

As the Training Rep, you will ensure all Ireland Operations Employees are compliant with all required global, EHS, and job specific training, as well as providing support for the Group Leader and serving as the LMS systems expert.

This is a Hybrid role where you will be required to work on site 3 days per week.

Key Responsibilities:

• Ensure the appropriate tracking and maintenance of training and certification records both electronically and hard copy in compliance to ISO13485 and FDA Part 820 regulatory requirements while working independently at the highest levels of quality and productivity with a proven capacity to learn and teach work on all operations to lower level staff
• Receive new employees directly from New Employee Orientation (NEO) and immediately begin training on site-specific general procedures and EH&S, as well as on global production training, including determining opportunities for program improvements and making recommendations
• Ensure manufacturing training and certifications are completed within allotted time requirements by frequently reviewing training status of all employees in LMS as well as following-up to ensure learning curve and competency are achieved; addressing training/certification needs before their due dates
• Serve as systems expert for LMS by answering questions from users of these systems and helping them to efficiently execute their work within these systems; may also propose training opportunities for basic system utilization training
• Provide input to and conduct Instructor Led Training (ILT) for general updates, in the clean room
• Contribute to content to and prepare training materials for both Read and Review and On The Job (OJT) methods of training
• Provide administrative support to Production Support/Group Leader by helping them complete their work in times of high demand and serve as their back-up during their absence
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE
• Other incidental duties: Collaborate with Manufacturing Engineers, Supervisors, and Quality Engineers to ensure training is implemented and records are maintained per operational sequences, work instructions, and processes in manufacturing

Education and Experience:

• Minimum Leaving Certificate

• 2 years relevant experience working with Quality Systems

Additional Skills:

• Strong interpersonal skills, written and verbal communication, required
• Ability to work in a fast paced team environment, required
• Expert knowledge with a variety of software packages, including MS Word, PowerPoint, Excel, and Outlook
• Must be able to receive and provide feedback in a professional, direct, and tactful manner.
• High level of self-directed initiative, organizational and recordkeeping skills, and attention to detail, required
• Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Extensive knowledge in specialized functions
• Expert knowledge in LMS systems
• Good understanding of products and production process
• Must be able to work in a team environment and with minimum supervision by relying on experience and knowledge gained on the job in conveying detailed instructions
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control