Job Title: Versatile Production Operator
Department: Operations
Reports to: Production Team Leader
Shift: Day Shift : 06.45am-15:00pm (Monday – Thursday) and 06.45am – 13:45pm (Friday)

GENERAL DESCRIPTION

The Versatile Production operator is responsible for the manufacture of Class III medical devices. This individual performs a variety of assembly and sub assembly operations of medical devices including test and packaging processes whilst ensuring they are adhering to GMP, GDP and Quality standards. This individual ensures that they are following MPI in the production of products and monitors both raw material and equipment to ensure both are without fault.

KNOWLEDGE AND EDUCATIONAL REQUIREMENTS

• Applies knowledge of MPI, business concepts, procedures and practices and a basic understanding of department fundamentals.
• Candidates must be educated to Leaving Certificate standard or equivalent.

COMPETENCIES AND SKILLS

• Good dexterity skills (for skiving etc.).
• Good PC skills/ PC Literacy
• Basic Numeracy
• Ability to learn quickly and the ability to learn technical information.
• Ability to use manual equipment including microscopes.
• Ability to collaborate and work with others, share information and ideas and take responsibility for actions & results within the team.
• Ability to adapt easily to changes in the business needs & work steps, flexible in order to meet individual & team objectives.
• Ability to work overtime when required.
• Effective communication skills in English (business language), both written & verbal. An active listener who clearly and effectively shares information & successfully communicates key messages.
• Embrace and develop a Kaizen mindset on a daily basis (desirable but essential).
• Strong attention to detail.
• Effective decision making – in line with procedure.
• Reliability and Conscientiousness - trustworthy, go above and beyond, take pride in their job.
• Proven track record in performing routine tasks working from detailed written or verbal instructions.
• Strong commitment to Quality, Safety, GMP & GDP.
• Previous med device or manufacturing experience (desirable).
• Previous experience working in a regulated environment (desirable).

• Work in a clean room environment in compliance with GMP (Good Manufacturing Practice) & GDP (Good Documentation Practice) in all elements of their work ensuring high standards are maintained.
• Ensures satisfactory set up of raw material or equipment ensuring Manufacturing Process Instruction (MPI) is followed correctly.
• Cleans tools, equipment and workstations per documented procedures and MPI.
• Assembles, inspects and/or test products following MPI.
• Records required information on approved documents and in real time e.g. LHR etc.
• Responsible for disposing of hazardous waste material in line with H&S regulations.
• Maintain a safe work environment for everyone (individual & colleagues) by abiding by H&S policies and documentation.
• Trains other employees on various steps when necessary and with agreement.
• Actively participate in Kaizen activities and problem solving when and if required.
• Achieves daily/weekly production output targets as per capacity plan and work-station targets.
• Communicates potential problems that may affect capacity & quality to the Team Leader where necessary.
• Be flexible and willing to learn all aspects of the assigned area / process.