We are Hiring

Goodman Medical Ireland Limited (GMIL) is a progressive and dynamic manufacturer of medical devices, mainly concerned with the development and manufacture of cardiovascular devices and implants.
GMIL has been operating successfully since 2004 and we have built our success on the belief that finding, employing and continually developing the right people is one of the keys to building a safe and effective medical devices.

Software Support Technician

Human Resources Generalist

Quality  Systems Engineer

IT Software Development Engineer

Software Support Technician

Background:

The Software Support Technician is responsible for the support and maintenance of the GMIL IT System. Reporting to the GMIL Lead Software Developer, the Software Support Technician will support the integration and implementation of the Production Scheduling System (ASPROVA). The Systems Support Technician will be the point of contact to support internal users, and ensure an efficient quality service is provided to all within GMIL. The Systems Support Technician will provide inputs to the GMIL IT System enhancement.

Major Roles & Responsibilities:
This role will involve reasonability for the following:

• To have an in-depth knowledge of work-station touch screens, and an in-depth knowledge of Database-Touchscreen interactions to be a specialist technical support to internal systems users.
• To have an in-depth knowledge of GMIL Database Schema, how the data is collected, process and stored.
• To be an SME in the ASPROVA scheduling system to provide essential technical support to scheduling/production users.
• To support off-the-shelf systems (ex. Label Print) where necessary to maintain optimal use.
• To support the advancement of the GMIL database system to become a fully integrated system providing real time accurate/reliable data.
• To complete systems improvement activities/projects in conjunction with Software Developers. Support software testing/verification work as required.
• To log and monitor trends to aid in prevention of repeat systems related issues.
• To develop and document training manuals for IT systems.  To deliver training to appropriate personnel when required.

Knowledge and Skills Required:

• Excellent Computer Skills (Word, Excel, Visual Basic, SQL, 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.
• Good organisational skills and ability to track and drive activities to closure.

Qualification and Education requirements:

• Minimum 2 years’ experience working in Information Systems environment. 
• Requires a Third Level qualification (diploma or degree) in IT systems design/development.
• An ability in number orientation (abilities in mathematics; accounting; statistics; and/or finance).

Human Resources Generalist

General Description:

The HR Generalist will provide a wide range of HR support services to the business and will be the first point of contact for all operational HR queries. This role will report to the HR Manager who provide support and advice for dealing with more complex HR issues or queries. If you are a self-starter, enthusiastic and organised, this is a great opportunity to further develop your HR skills and experience.

Responsibilities

• Responsible for all recruitment and selection activity – collaborate with the business on their recruitment requirements.
• Manage day-to-day HR operations, including ongoing review of HR related policies and procedures in line with relevant employment law and best practice.
• Responsible for the management of TMS system.
• Oversees and administers the company’s HR Systems serving as the primary point of contact.
• Ensures compliance with company policy.
• Promotes employee engagement helping to nurture a positive working environment
• Responsible for the management of employee records and correspondence.
• Manages and ensures accurate and timely information is recorded on all HR systems as required.
• Support the handling of employee relations issues including disciplinary, grievances, absenteeism when appropriate.
• Maintain HR analytical tools, reporting and dashboards. This includes maintenance of data to support HR analytics needs and ensuring accuracy and consistency of key data sets, reports and metrics.
• Promote and encourage formal and informal communication.
• Responsible for updating reports on absenteeism, attrition etc.
• Leads and manages ad hoc projects as assigned or identified.
• Perform regular audits on files to ensure data and system integrity.
• Follow all environmental, health & safety rules and procedures and participate in safety and environmental activities in order to improve the workplace for all employees.
• Leads or support data analytics/metric improvement initiatives.
• Identifies and executes on continuous improvement of HR programmes and processes to improve the overall employee benefits.
• Responsible for overview of Compensation & Benefits including Pension, Health Insurance, Bonus etc.
• Preparation of HR reports, analytics & KPI’s, maintain workforce measures and metrics to ensure visibility and accountability.

Requirements and Education

Requires a Level 8 or higher degree in a human resources or business discipline with a minimum of 3 years of related experience. CIPD membership highly advantageous.

Advanced to expert knowledge of TMS (Advanced Systems) required.

Strong recruitment experience highly desirable.

Strong knowledge of Irish employment law.

Excellent communication and problem-solving skills.

Ability to prioritise, multitask, think ‘on your feet’ and communicate effectively.

Strong attention to detail.

IT Software Development Engineer

Background:

The IT Software Development Engineer is responsible for identifying systems support opportunities, and designing/developing advanced systems solutions to support GMIL’s evolving business. Reporting to the GMIL Lead Software Developer, the IT Software Development Engineer will co-ordinate day to day activities required to maintain and upgrade GMIL’s existing customized IT system, whilst also evaluating and seeking out new solutions aligned to GMIL’S broader ERP system. The IT Software Development Engineer will work as part of the IT Systems team and will work closely with all Functions within GMIL to co-ordinate implementation (including validation) of Systems solutions. The IT Software Development Engineer will support users and engage in troubleshooting / systems maintenance activities where necessary.

Major Roles & Responsibilities:

This role will involve reasonability for the following;

• Be an SME for all GMIL Information Systems hardware, software and network operating systems.

• Develop a baseline standard for GMIL’s ERP system, and taking a collaborative approach, develop a roadmap for a future ERP system. Have all stakeholders in agreement/alignment with this direction.

• Project-manage advanced application/new application introductions in a structured and professional manner.

• Verify/test data inputs and outputs prior to making information systems update releases to ensure compliance with existing reporting functionality.

• Support the Lead Software Developer with Database programming as necessary. Maintain familiarization with Database design.

• Align closely with validations to ensure that all customized IT solutions are fully validated prior to release/implementation.

• Develop an appropriate database control system to protect the system integrity during upgrade/new change activities.

• Generate systems documentation and User training documents. Provide training where necessary.

• Troubleshoot information systems hardware, software and network systems issues.

• Co-ordinate/complete Information Systems Preventative Maintenance tasks. Maintain repairs/maintenance log.

• Provide inputs at Budget planning process for targeted IT systems upgrades/investments.

• Research current and potential Information systems and services keeping up to date with latest advancements.

• Generate Company Related Reports based on company requirements and KPI’s.

• Monitor security of all Information Systems technology.

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:

• Minimum 3 years’ experience working in Information Systems environment.

• Related Information Technology Development / Support qualification.

• Good Programming Skills in C-Sharp and T-SQL (SQL Server).

• Required to be knowledgeable in MS Access; SQL Server and SSRS.

• Required to have strong communication skills.

• Experience in Web Database Applications desired but not essential.

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 of 4 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 Quality 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 GMP requirements is highly desirable.