CAREERS

Open Positions

Line Equipment Technician

General Description:

The line equipment technician is a key function in the successful operation of the manufacturing line. Their function is to be the SME for equipment primarily and support processes within the manufacturing area. The role requires the technician to be an ever-present support to the area, providing value add technical expertise to equipment issue resolution but also maintaining a state of operation at all time. The technician will own the downtime of equipment metric and the product yields. The technician be responsible for maintaining these metrics to target, through effective monitoring and evaluation/analysis of the process and the equipment to ensure optimal product output.

Role & Responsibilities:

• To take ownership and responsibility for the technical performance/reliability of equipment to target zero downtime in the technician’s area relating to equipment fault through proactive equipment management.
• A mindset of continuous improvement is a must and always working towards this goal in a structured manner.
• Constantly evaluate equipment & process inputs/outputs to ensure optimal visual and functional product performance and take action before it impacts on uptime or yield.
• Complete PMs on time and improve when found deficient to ensure optimal equipment performance at all times.
• Identify requirements for jigs/fixtures to improve work station efficiency or yield improvement and carry through into manufacturing through the approval process with supporting data on the potential gains to be achieved.
• To ensure tooling including mandrels/ trim fixtures etc. are available to the line when required and are in optimal working order and fit for purpose.
• Ensure and maintain a sufficient Kanban & robust process for consumable equipment spares in CER to minimise downtime.
• To support onloading of new technician hires when required.
• The technician must be fully competent in manufacturing product through all work steps and in identifying Accept and Reject samples for all steps. Understand the intended use and the impact of defects on the use of the product or efficacy.
• To continually review the manufacturing process for improper application of work methods and equipment settings.
• Communicate promptly, clearly & effectively at all times, to the Line Lead & Line Support Technician with regard to equipment & process issues with a clear plan for resolution that is data driven.
• Support for maintaining accurate up-to-date documentation for LHR’s MPI’s, Drawings and PM documentation.

Qualifications and Education Requirements:

• Requires a Diploma/Degree in Engineering or equivalent (preferably Mechanical or Mechatronics)
• Industrial experience in a medical device/pharma background is preferred. Experience with automated equipment desired.
• Very strong technically with a good eye for detail. Excellent trouble shooting & fault finding skills with logical and data driven approach to problem solving.
• Demonstrated process and continuous improvement mind set.
• Excellent time management, organisational, communication and interpersonal skills.
• Highly motivated with good initiative and strong work ethic.
• Ability to work independently or as part of a team.
• Strong commitment to Quality, safety and GMP standards.

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Warehouse Assistant

General Description

The function of warehouse assistant is to ensure the GMIL warehouse operates in an efficient, responsive, and effective manner. This individual will ensure that all warehouse systems are maintained in line with real time . They will also maintain high standards whilst ensuring all procedures are followed . This individual actively contributes to the enhancement of compliance initiatives for areas of responsibility and adheres to strict compliance with all company’s policies & procedures.

Key Roles & Responsibilities:

• Demonstrate GMP (Good Manufacturing Practice) & GDP (Good Documentation Practice) in all elements of their work ensuring high standards are maintained, work procedures and specifications are followed.
• Monitor and control all warehouse inventory by completing routine cycle count activities and maintaining accuracy across all inventory levels.
• Support commercial & non commercial (validation) production through timely Kanban replenishment & use of move ticket process (material release).
• Perform the kitting and verification of all lots issued to the final assembly lines and balloon forming.
• Maintain a FIFO system in the Warehouse and provide a system to alert inventory expiry issues.
• Maintain minimum inventory levels of raw material, consumables and cleaning agents at point of use.
• Responsible for the replenishing of the warehouse kanbans.
• Manage all consumables and maintain usage records.
• Replenish on a daily basis, all cleanroom supplies ( ie gloves; wipes; mop-caps; shoes etc )
• Ensure sufficient volumes of point of use 70% IPA and 99% IPA are available as required.
• Make necessary inventory transactions on the Inventory Control System in a timely; efficient, and accurate manner.
• Co-ordinate and complete the receipt and dispatch of goods ( finished product and sample shipment ) within GMI.
• Support production where possible by becoming proficient on product assembly stations ( Luer printing; stent passivation; final packaging; balloon testing ).
• Operate the forklift for removal or loading of items in line with H&S guidelines.

To complete specific GMI warehouse duties as follows:

• Switch high pressure Nitrogen bottles; Empty bins as required; Bale waste recyclables; Replenish hygiene consumables in gowning room, canteen and toilet facilities; powering on/off equipment ( compressor; water drain machine; air exchange unit ); arming alarm; ensure chemical store is safe and tidy at all times;
• Maintain the warehouse, yard and material pass throughs to high housekeeping standards.
• Assembly of Boxes in Packing area for Isotron Shipments

Knowledge and Education 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.

Skills and Abilities:

• Good working knowledge of Microsoft Office Packages including Word, Access, Excel.
• Excellent organisation skills and ability to maintain accurate records.
• Ability to work independently or in a collaborative manner as part of a cross departmental team.
• Ability to collaborate and work with others, share information and ideas and take responsibility for actions & results within the team whilst being supportive of work colleagues.
• Ability to adapt easily to changes in the business needs .
• Flexible in order to meet individual & team objectives.
• Ability to work overtime when required.
• Excellent communication skills in English (business language), both written & verbal. An active listener who clearly and effectively shares information & successfully communicates key messages.

Other Characteristics / requirements:

• Strong attention to detail.
• Effective decision making – the ability to ‘ think on your feet’.
• Reliability and Conscientiousness – trustworthy, go above and beyond , takes pride in their job.
• Proven track record in performing routine tasks working from detailed written or verbal instructions.
• Strong commitment to Quality, Health & Safety , GMP & GDP.
• Previous experience working in a warehouse environment (desirable).
• Flexible and highly motivated.

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Production Planner

General Description:

Reporting to the Group Production Lead, the role of the Production Planner is to co-ordinate and control the generation and issuance of Production Schedules for all GMIL products. For Commercial Production, this includes Production Schedules/TQ Schedules for Balloon Forming, Sub Assembly Schedules, and Final Assembly/Packaging Schedules. For Non-Commercial Production, this includes Production builds for Engineering Validation activities, Engineering Trial builds, and Engineering builds for New Product Introductions.

The Production Planner will generate weekly Production Schedules by using GMIL/ASPROVA Scheduling System. The Production Planner will generate and issue an updated Product Shipping File on a weekly basis to Goodman/Nipro and GMIL Commercial teams.

Roles & Responsibilities:

• To download new Purchase Orders received ( from Goodman/Nipro Commercial dept ) on to the GMIL/ASPROVA Scheduling System.
• To review, generate, and issue, weekly production schedules for all production processes to Production Team Leaders using the GMIL/ ASPROVA Scheduling System.
• To review, generate, and issue, Weekly Production Schedules for Non-Commercial Product based on approved Engineering build requirements.
• To liaise with Production Team Leaders to monitor daily production schedules against the GMIL/ASPROVA-generated weekly schedules.
• To update and maintain the Master production Schedule.
• To verify the accuracy of the GMIL/ASPROVA-generated Weekly Product Shipping File.
• To circulate the GMIL/ASPROVA-generated Weekly Product Shipping File to Goodman/Nipro and GMIL Commercial teams.
• To report on weekly performance against schedule and where possible have disparities resolved.
• To prepare and present the monthly commercial data to the Goodman/Nipro Commercial group.
• To liaise with the Commercial group regarding model size prioritization and report LRT issues and product supply issues/constraints.
• To participate in continuous improvement activities to improve the scheduling/product supply process in GMIL

Qualification and Education requirements:

• 3-4 year’s experience in a similar role, (preferably within a Regulated manufacturing environment) would be an advantage.
• Significant experience using MRP / ERP systems, especially Advance Planning Systems and forecasting tools.
• APICS certification (CPIM or CSCP) is an advantage but not essential.
• Lean/Continuous Improvement Qualifications would be an advantage

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Quality Systems Engineer

Background:

Reporting to the Quality Manager, the Quality System Engineer is a team member of the Quality team with responsibility for establishing, implementing and maintaining the Quality System onsite.

Working in the QA Dept, this person will have day to day responsibility for the running of QA based systems; document control, monitoring and development of all Quality System components running of NCR and CAPA systems, oversight of Labelling control system.

The successful candidate will liaise and collaborate with various departments including engineering, operations etc. to ensure the quality system is in compliance. This role includes people management and the successful individual may have up to a team of2 reporting directly to them.

Major Roles & Responsibilities:

This role will involve reasonability for the following;

• Identify and implement effective process control systems to support the continuous improvement of the quality systems as a whole.

• Oversee and be actively involved in all QA office systems and functions.

• Direct involvement in routine Document Control, NCR and TA activities.

• Develop and implement quality metrics and reporting systems.

• Support and deliver continuous improvements and to employ problem solving tools including root cause analysis and CAPA identification.

• Preparation of Quality reports for Quality meetings and management reviews.

• Oversee all in house label control systems.

• Acts as an effective team member in supporting quality disciplines, decisions and practices.

• Facilitate the New Product Introduction processes along with other Engineering functions to ensure NPI procedures are efficient and effective in satisfying the QMS/ Customer requirement.

• Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues.

• Suggest changes in procedures and standards to facilitate work efficiency and maintain quality.

• Ensure regulatory compliance to GMP for all medical device regulatory agencies.

• Participates in new product/technology development and supports the QA activities as part of an overall project team.

• Perform an active role in continual improvement of the Quality System.

• Conduct internal quality audits to ISO13485 and GMP requirements.

• Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system.

• Undertake special projects as required.

• Contribute to continuous improvement activities.

• Take part in third part audits as required.

Knowledge and Skills Required:

• Demonstrable Knowledge of medical device quality systems and ISO13485.

• Excellent Computer Skills (word, excel, PowerPoint and Access).

• Excellent communication (both verbal and written) & interpersonal skills.

• An analytical approach to problem solving.

• A self-starter that applies their own initiative in most situations.

• A team player, who works well in a smart team environment, must be able to work effectively with peers in other departments.

• A good communicator who can easily convey his/her ideas and requirements across all levels in the organisation.

• CAPA, Auditing and Risk Management experience.

• Good organisational skills and ability to track and drive activities to closure.

Qualification and Education requirements:

• Requires a Level 8 or higher degree in an engineering or science discipline.

• Previous experience within the medical device industry in a Quality Systems Engineer role is essential.

• Minimum of 4 years of quality experience in a quality function with proven quality assurance experience within Medical Devices.

• Recent experience with FDA/NDSAP GMP requirements is highly desirable.

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