Process Technician - Days

Process Technician - Nights

Process Technician - Weekends

Associate MDR/Vigilance Specialist 12 month contract&nbsp; Hybrid - Galway&nbsp; Key Responsibilities
Responsibilities may include the following and other duties as assigned:
<ul>
<li>Monitors the company's drug or medical device surveillance programme, including the intake, protocol development, evaluation, processing and follow-up of adverse event reports.</li>
<li>Participates in the resolution of potential legal liability matters and ensures compliance with applicable government regulations.</li>
<li>Ensures the complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data and adverse reaction data, as required by regulatory agencies.</li>
<li>Reviews and analyses clinical databases to extract ADE data and integrates information to establish a unified database.</li>
<li>Ensures databases are consistent with the objectives of ADE standardisation and internalisation, while maintaining the accuracy and quality of safety summaries.</li>
<li>Acts as a liaison with internal teams and external collaborators to develop programmes and processes that meet regulatory reporting requirements.</li>
</ul>
Specialist Career Stream
Typically an individual contributor with responsibility within a professional discipline or specialty.
<ul>
<li>Delivers and/or manages assigned projects, working collaboratively with stakeholders to achieve desired results.</li>
<li>May act as a mentor to colleagues or direct the work of other lower-level professionals.</li>
<li>Spends the majority of their time delivering and overseeing projects from design through to implementation.</li>
<li>Works in accordance with established policies, applying specialised knowledge and skills normally acquired through advanced education.</li>
</ul>
Differentiating Factors
1. Autonomy
<ul>
<li>Entry-level individual contributor working on a project or within a team.</li>
<li>Works under close supervision.</li>
</ul>
2. Organisational Impact
<ul>
<li>Delivers work of limited scope, typically involving smaller, less complex projects or related activities.</li>
</ul>
3. Innovation and Complexity
<ul>
<li>Identifies, defines and addresses problems that are not immediately evident but are generally not difficult or complex.</li>
<li>Makes minor changes to systems and processes to resolve problems.</li>
</ul>
4. Communication and Influence
<ul>
<li>Communicates primarily with internal contacts within the immediate team.</li>
<li>Contacts others to gather, confirm and communicate information.</li>
</ul>
5. Leadership and Talent Management
<ul>
<li>Not applicable. Roles at this level are focused on individual development.</li>
</ul>
Required Knowledge and Experience
<ul>
<li>Requires broad theoretical job knowledge, typically obtained through advanced education.</li>
<li>Requires a Bachelor's degree (or, for degrees earned outside the United States, a degree that satisfies the requirements of 8 C.F.R. &#167; 214.2(h)(4)(iii)(A)).</li>
<li>No previous professional experience required (0 years).</li>
</ul>

Associate MDR/Vigilance Specialist

Job Description Job Title: Design Quality Assurance Engineer
The Design Quality Assurance Engineer provides quality support and leadership throughout the product development lifecycle, ensuring compliance with regulatory requirements, industry standards, and the Quality Management System. The role supports New Product Development (NPD) programs through design controls, risk management, quality documentation, supplier engagement, and continuous improvement activities to ensure the successful development and commercialization of safe and effective medical devices.
Essential Job Duties and Responsibilities
<ul>
<li>As a lead Quality Engineer on projects, directly contributing and/or providing guidance to others to establish quality documentation. Providing detailed planning for pilot production and scale-up plans in New Product Development programs.</li>
<li>Ensuring project teams are utilizing Quasar Medical Quality Systems and appropriate regulations and industry standards throughout the product development process.</li>
<li>Conducting risk assessments of the design to determine ability to function as intended.</li>
<li>Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and vendor audits, product release, document control, design control process and design history files (DHF), device master records, etc.</li>
<li>Interacting with customer and supplier companies in a professional manner; proactively communicating with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required.</li>
<li>Intervening and contributing to successful resolution of technical issues when they arise.</li>
<li>Ensuring that all work satisfies the requirements of the company's Quality Management System.</li>
<li>Supporting continuous improvement projects</li>
<li>Leading Quality roles on client programs, assisting in the design and implementation of new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation.</li>
<li>Maintaining detailed documentation throughout all phases of research and development, often leading documentation of user needs, product requirement and risk / test planning and execution activities.</li>
<li>Coordinating activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.</li>
<li>Provide document and quality system support during internal, customer, supplier, and regulatory audits</li>
</ul>
Education and Experience Requirements
<ul>
<li>Minimum Bachelor's degree in Engineering or related field.</li>
<li>3 years of medical device design and development/quality assurance experience is required.</li>
</ul>
Preferred Skills and Abilities
<ul>
<li>Managing customer relationships and responses in aa timely manner.</li>
<li>Ability to interact with client companies in a professional manner.</li>
<li>Demonstrated ability to lead product verification &amp; validation activities</li>
<li>Experience working with operations to develop strong manufacturing process instructions is desired.</li>
<li>Familiarity with FDA QSRs, medical device regulations and ISO 13485</li>
<li>Knowledge of probability and statistics.</li>
<li>Organised and able to self-manage project tasks.</li>
<li>Customer focus with excellent communication skills, written and oral.</li>
<li>Experience using an electronic quality management system (eQMS) a plus.</li>
<li>Lean or Six Sigma certification/experience.</li>
<li>Auditor experience preferred (i.e. Supplier, Customer, Third Party, Quality Management System (QMS))</li>
<li>Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.</li>
</ul>

Design Quality Engineer

<p style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">Electrical Design Engineer - Kerry
<p style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">Our client is known as a pioneer for future-oriented, high-quality innovations. It&#146;s an international company and they continue to manage the company and Irish site in the tradition of the company founder, thus ensuring continuity and security.
<p style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">The Electrical Design Engineer will be responsible for the timely completion of Electrical Design on project-based products to the highest standard. They will promote the level of technical excellence relating to Electrical Engineering within the team. They will be confident to provide ideas and solutions.
<p style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">In this role you will:
<ul style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">
<li>Manage electrical requirements and ensure all requirements are fulfilled.</li>
<li>Liaison with customers in respect of design requirements and details.</li>
<li>Document the electrical system interfaces (EI drawing / Single line diagram)</li>
<li>Document control console layouts and functions.</li>
<li>Generate specifications for electrical equipment including switchgear.</li>
<li>Manage the integration of electrical sub systems and solutions, to ensure overall electrical function is delivered.</li>
<li>Ensure switch gear design engineers are aware of all electrical requirements, where necessary prepare function descriptions and other support documents.&nbsp;</li>
<li>Ensure software developers are aware of the electrical integration requirements, where necessary document interface protocols and participate in software testing.</li>
<li>Ensure software developers are aware of monitoring requirement for electrical systems, where necessary document requirements and verify implementation.</li>
<li>Specify electrical components and source suppliers.</li>
<li>Liaise with production and installation departments to ensure assembly and testing of electrical systems are carried out to the necessary standards..</li>
<li>Prepare of Technical documentation for assembly, installation, commissioning and customers.</li>
</ul>
<p style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">Ideally you will have:
<ul style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">
<li>Level 7 degree in any of the following disciplines: Automation / Electrical / Electronic /Mechatronic Engineering</li>
<li>Confident at challenging the status quo and open to adapting new technologies or techniques.</li>
<li>&nbsp;Familiarity with Zuken E3 or similar drawing package.</li>
<li>Ability to manage project requirements and schedules.Willingness to travel internationally as required</li>
</ul>
<p style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">For more information on this role please contact Regina Carroll 086 0100901 or jobs@hero.ie
<p style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">Check out all our open jobs on our HERO Recruitment website &#150;&nbsp;<a href="https://www.hero.ie/" target="_blank" rel="noopener">https://www.hero.ie/</a>
<p style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval
<p style="color: #000000; font-family: 'Times New Roman'; font-size: medium; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Electrical Design Engineer 

I specialise in talent acquisition for diverse industries across Ireland. With a robust experience spanning over three decades, HERO Recruitment has earned a stellar reputation for our unwavering passion and commitment to excellence.
Our client portfolio is broad, covering sectors such as medical devices, pharmaceuticals, manufacturing, IT, and more. Armed with extensive connections, I can confidently locate the perfect match for you.
However, let's shift the focus to you &ndash; your dreams and goals are my driving force. Beyond being a recruiter, I am your dedicated partner, ready to guide you through every step of your journey. Together, we will navigate through various opportunities and transform your career aspirations into reality.
Join the HERO Recruitment family today, and let's co-create a success story that is uniquely yours. Together, we will make a substantial impact in the industry. Are you ready? Let's make it happen.

Job Details

Process Technician - Weekends

Recruitment Consultant