Senior Quality Systems Specialist Job Title: Sr. Quality Systems Specialist&nbsp; Duration: 12 Months&nbsp; Job Type: Remote in Ireland
Job Purpose
Provides specialist expertise and oversight for the development, maintenance, and continuous improvement of quality systems, processes, and procedures. Ensures compliance with company policies, regulatory requirements, and established quality standards across the organisation.
Key Responsibilities
<ul>
<li>Oversee the development, maintenance, and improvement of quality systems, programs, processes, and procedures.</li>
<li>Provide expert guidance on quality policies, regulatory requirements, and compliance expectations.</li>
<li>Partner with operating entities to monitor processes, identify gaps, and ensure ongoing compliance.</li>
<li>Lead Quality Agreement negotiations and ensure agreements and quality programs are maintained and updated.</li>
<li>Promote consistent global quality standards and facilitate sharing of best practices.</li>
<li>Lead or contribute to quality systems and process improvement projects.</li>
<li>Analyse complex quality issues and provide recommendations to improve compliance and performance.</li>
<li>Collaborate with senior internal and external stakeholders, customers, and vendors to resolve quality issues and achieve objectives.</li>
<li>Provide coaching, guidance, and training to colleagues and less experienced professionals.</li>
</ul>
Role Scope
<ul>
<li>Specialist Career Stream: Experienced individual contributor with responsibility for a specialist area. Works independently with limited supervision and may lead projects, processes, and cross-functional initiatives.</li>
<li>Applies advanced knowledge to complex quality and compliance issues.</li>
<li>Develops and implements process and system improvements.</li>
<li>Influences stakeholders through specialist expertise, analysis, and recommendations.</li>
<li>May mentor colleagues and coordinate or review the work of other professionals.</li>
</ul>
Required Knowledge &amp; Experience
<ul>
<li>Advanced knowledge of quality systems, quality assurance, compliance, and relevant regulatory requirements.</li>
<li>Strong analytical, problem-solving, communication, negotiation, and stakeholder management skills.</li>
<li>Practical project management experience.</li>
<li>University Degree and minimum 4 years' relevant experience, or Advanced Degree and minimum 2 years' relevant experience.</li>
</ul>

Senior Quality Systems Specialist 

MES Change Management Lead
Sector:&nbsp; Medical Devices
Engagement:&nbsp; Contract
Level:&nbsp; Senior / Lead
Location: &nbsp;Galway
Duration: 12 months
The Opportunity
Our client, a leading global medical device manufacturer at their Galway facility, is embarking on a significant digital manufacturing programme and is looking for an experienced MES Change Management Lead to help drive it forward.
This is a pivotal contract role for someone who thrives at the meeting point of technology, quality and people. You’ll own the change management process for the site’s Manufacturing Execution System (MES) ensuring every change is delivered compliantly, safely and with the buy in of the teams who use the system every day. You’ll work with senior leadership, site wide managers, engineers and product builders to embed new ways of working and keep the operation moving.
The Role
Reporting to the Site lead you will lead the end-to-end change management for the MES platform across the site covering both the technical change control that keeps the system validated and compliant, and the organisational change that gets people confidently using it.
Key Responsibilities
<ul>
<li>Lead and govern the change control process for the MES platform, from change request through impact assessment, approval, implementation and closure.</li>
<li>Own change management for MES driven manufacturing including electronic batch records, workflows and master data ensuring changes are risk assessed and controlled.</li>
<li>Partner with senior leadership to plan, prioritise and sequence changes in line with the digital manufacturing roadmap and production schedules.</li>
<li>Coordinate cross functional stakeholders across Production, Quality, IT/Automation, Validation and Engineering to deliver changes with minimal disruption to the line.</li>
<li>Ensure all changes meet GxP requirements, data integrity expectations and applicable regulations.</li>
<li>Oversee the computer system validation (CSV/CSA) activities associated with MES changes, working closely with validation teams and documentation owners.</li>
<li>Manage change documentation updating SOPs, work instructions and training materials so they stay accurate and audit ready.</li>
<li>Drive the people side of change prepare, engage and train managers, engineers and product builders so new MES workflows are adopted quickly and confidently.</li>
<li>Support deviation, CAPA and audit activities relating to MES changes, and act as a point of contact during regulatory and customer audits.</li>
<li>Contribute to MES upgrades, new module rollouts and paperless / Industry 4.0 initiatives as the site matures its digital manufacturing capability.</li>
</ul>
About You
Essential
<ul>
<li>Proven experience leading change management within a regulated MES / digital manufacturing environment ideally in medical devices, pharma or a comparable GxP setting.</li>
<li>Strong working knowledge of an MES platform.</li>
<li>Solid understanding of change control and quality management systems and of validated computer systems.</li>
<li>Excellent stakeholder management able to influence and align senior leaders, technical teams and product builders alike.</li>
<li>Confident communicator who can translate technical change into clear, practical guidance for the people affected by it.</li>
</ul>
Desirable
<ul>
<li>Degree in Engineering, Manufacturing, Computer Science, Life Sciences or a related discipline.</li>
<li>Formal project or change management credentials (e.g. PMP, PRINCE2, Prosci / ADKAR, Lean Six Sigma).</li>
<li>Experience supporting MES implementations, upgrades or migrations.</li>
<li>Familiarity with ISO 13485 and EU MDR in a medical device context.</li>
<li>Prior experience in a matrixed, multi-site or global manufacturing organisation.</li>
</ul>
.

MES Change Management Lead

<div style="font-family: 'Segoe UI'; font-size: 14px; font-style: normal; font-weight: 400; line-height: 20px;">
<h1>Tooling Support Technician / Toolmaker</h1>
Leixlip, Co. Kildare | Full-Time
Are you a hands-on Toolmaker or skilled tradesperson looking to join a growing, high-tech manufacturing environment?
We're seeking a Tooling Support Technician / Toolmaker to join our Tooling team in Leixlip. This is an excellent opportunity to work with advanced injection moulding technology, support new product introductions, and play a key role in maintaining high-precision tooling within a fast-paced manufacturing facility.
<h3>What You'll Be Doing</h3>
<ul>
<li>Repairing and maintaining high-precision injection moulds, including multi-cavity, hot runner, valve-gated and stack moulds.</li>
<li>Supporting tool builds, tool changes, trials and validations.</li>
<li>Manufacturing and repairing jigs, fixtures and mould spare parts.</li>
<li>Troubleshooting tooling issues alongside Production and Engineering teams.</li>
<li>Driving continuous improvement initiatives and contributing to process enhancements.</li>
<li>Ensuring compliance with quality, safety and GMP standards.</li>
</ul>
<h3>What We're Looking For</h3>
<ul>
<li>Toolmaking qualification desirable but not essential.</li>
<li>Trade background (Mechanical, Electrical, Carpentry or similar) advantageous.</li>
<li>Experience in a manufacturing or regulated GMP environment.</li>
<li>Strong problem-solving skills and attention to detail.</li>
<li>Excellent teamwork and communication skills.</li>
<li>Experience with mills, lathes and surface grinders is highly desirable.</li>
<li>Forklift and Lock Out/Tag Out experience an advantage.</li>
</ul>
<h3>What's On Offer?</h3>
<ul>
<li>Competitive salary (DOE)</li>
<li>Healthcare subsidy</li>
<li>Private pension scheme</li>
<li>Career development opportunities</li>
<li>Exposure to industry-leading tooling and manufacturing technology</li>
<li>Collaborative and supportive team environment</li>
</ul>
If you're a motivated, practical problem-solver who enjoys working with precision engineering and tooling, we'd love to hear from you.
<h3>Interested?</h3>
For further information on this role, please contact Eugene Clarke on 086 440 3724 or email engineering@hero.ie.
Check out all our open jobs on the HERO Recruitment website: https://www.hero.ie/
Please Note: Under its obligations under Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
Data can only be transferred outside of the EEA on the basis of Standard Contractual Clauses, to a country for which an adequacy decision has been granted by the European Commission, or where the express permission of the data subject has been obtained. You have supplied us with your personal data as part of your application process. Our client company may have personnel outside of the EEA who will review applications as part of the recruitment process.
#Toolmaker #ToolingTechnician #ManufacturingJobs #EngineeringJobs #InjectionMoulding #Toolroom #KildareJobs #LeixlipJobs #MaintenanceTechnician #ProductionEngineering #HiringNow #IrelandJobs #HERORecruitment #EngineeringCareers
</div>

Tooling Support Technician / Toolmaker

Design Assurance Engineer
12-Month Contract | Galway (4 Days Onsite Preferred)
About the Role
We are partnering with a leading global medical device company to recruit a Design Assurance Engineer for a high-profile 12-month contract. This role will support a major acquisition and integration programme within the rapidly growing renal denervation portfolio, contributing to the development and integration of innovative Class II/III medical technologies.
The level is flexible and can accommodate candidates with strong Design Assurance experience or those with relevant Quality or Product Development backgrounds looking to move into a design-focused role.
Key Responsibilities
<ul>
<li>Provide Design Assurance support across an acquisition and product integration programme.</li>
<li>Ensure compliance with design control requirements throughout the product development lifecycle.</li>
<li>Participate in risk management activities including risk assessments, FMEAs and risk documentation.</li>
<li>Support design changes, engineering change control and Design History File (DHF) documentation.</li>
<li>Collaborate with cross-functional teams including R&amp;D, Manufacturing, Regulatory Affairs and Quality.</li>
<li>Drive quality activities including CAPA, non-conformance investigations and continuous improvement initiatives.</li>
<li>Ensure products meet internal quality standards and applicable regulatory requirements.</li>
</ul>
What We're Looking For
Essential
<ul>
<li>Degree in Mechanical, Biomedical, Electronic or related Engineering discipline.</li>
<li>Previous experience in Design Assurance, or relevant experience in Quality Engineering or Product Development within medical devices.</li>
<li>Strong understanding of Design Controls and Risk Management.</li>
<li>Experience working with Class II or Class III medical devices.</li>
<li>Knowledge of core quality systems including Change Control, CAPA and compliance processes.</li>
<li>Ability to work effectively within cross-functional engineering teams.</li>
</ul>
Desirable
<ul>
<li>Experience with medical electrical systems.</li>
<li>Previous experience with Boston Scientific or another large multinational medical device company.</li>
<li>Familiarity with acquisition, integration or new product development projects.</li>
</ul>
Contract Details
<ul>
<li>12-month hourly rate contract</li>
<li>Galway | 4 days onsite preferred</li>
<li>Renal Denervation | Acquisition &amp; Integration Programme</li>
</ul>

Design Assurance Engineer

Quality Engineer 
<p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 14px; vertical-align: baseline; background: none 0% 0% / auto repeat scroll padding-box border-box #ffffff; font-weight: 400; --artdeco-reset-typography_getfontsize: 1.4rem; --artdeco-reset-typography_getlineheight: 1.42857; line-height: 1.42857; color: rgba(0, 0, 0, 0.9); --hue-web-line-height-regular: 1.25; --hue-web-line-height-open: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; 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;">6 Month Contract with potential to be extended or made permanent
<p style="box-sizing: inherit; margin: 0px; padding: 0px; border: 0px; font-size: 14px; vertical-align: baseline; background: none 0% 0% / auto repeat scroll padding-box border-box #ffffff; font-weight: 400; --artdeco-reset-typography_getfontsize: 1.4rem; --artdeco-reset-typography_getlineheight: 1.42857; line-height: 1.42857; color: rgba(0, 0, 0, 0.9); --hue-web-line-height-regular: 1.25; --hue-web-line-height-open: 1.5; font-family: -apple-system, system-ui, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Fira Sans', Ubuntu, Oxygen, 'Oxygen Sans', Cantarell, 'Droid Sans', 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Lucida Grande', Helvetica, Arial, sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; 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;">Galway
&nbsp;
Job Purpose:
As an experienced Quality Engineer, you will demonstrate commitment to the Quality Policy (patient safety and product quality) through daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Committed to patient safety and product quality.
Key Responsibilities:
<ul>
<li>Takes a preventive approach to Quality Assurance, proactively identifying potential issues.</li>
<li>Uses strong organisational skills and effective time management to ensure work is completed in a timely manner.</li>
<li>Effectively prioritises a diverse workload to ensure timely completion of critical tasks.</li>
<li>Plans and executes both daily tasks and long-term projects to ensure timelines are met.</li>
<li>Takes a pragmatic and logical approach to challenges faced.</li>
<li>Explains technical topics clearly to diverse stakeholders through effective communication.</li>
<li>Promotes a culture of continuous improvement through reflection and factoring in previous learnings.</li>
<li>Makes informed decisions related to product quality, including dispositioning non-conforming product.</li>
<li>Evaluates complex quality issues and selects the most appropriate problem-solving tools/ techniques.</li>
<li>Completes timely scoping and containment of product-related issues when required.</li>
<li>Documents non-conformances using a high standard of technical writing and detailed understanding of Containment, Disposition, Risk Assessment and Investigation.</li>
<li>Identifies and drives Corrective Actions when required, to prevent/ eliminate/ facilitate/ mitigate the re-occurrence of non-conformances.</li>
<li>Reviews Complaints&#146; signals and completes investigations for individual events/ unfavourable trends.</li>
<li>Familiar with BSC Quality Systems and ISO/MDD/MDR standards.</li>
<li>Involved in internal and external audits, including audit facing and presenting processes/ documents to auditors as a subject matter expert.</li>
<li>Knowledgeable on Risk Management, Design Outputs and product/ process Risk Documentation.</li>
<li>Uses appropriate statistical tools for sampling, capability, trend analysis, and control charts. Effectively interprets and presents conclusions drawn.</li>
<li>Participates directly in a new product/technology transfer, ensuring compliance to all internal and regulatory requirements.</li>
<li>Uses knowledge of Six Sigma, Statistical Analysis and Lean Principles to solve problems effectively.</li>
<li>Involved in change control for work instructions, protocols/ reports and technical documents, either as a change owner or quality approver.</li>
<li>Evaluates new equipment/processes/chemicals for safety and environmental impact/effect, in conjunction with EH&amp;S.</li>
<li>Completes validations for processes/ test methods in line with requirements and best practices.</li>
<li>Maintains relationships and gives technical guidance to Quality Technicians.</li>
<li>Deals with suppliers, other engineering disciplines within and outside of the site as required.</li>
</ul>
Education &amp; Experience:
<ul>
<li>A Level 8 Degree or equivalent in a STEM discipline.</li>
<li>A minimum of 3+ years relevant experience, ideally within the Medical Device industry or another highly regulated environment.</li>
<li>Manufacturing/operational experience desired.</li>
</ul>

Quality Engineer 

Tooling Engineer
Location: Leixlip, Co. Kildare
Our client, a leading medical device manufacturer, is seeking an experienced and proactive Tooling Engineer to join their fast-paced injection moulding operation, reporting to the Tooling Manager. This role will support the full lifecycle of injection mould tooling &#151; from design and validation through to production release &#151; while driving continuous improvement and acting as the technical interface between customers, toolmakers, and internal teams. The successful candidate will bring hands-on experience with multi-cavity injection mould tools and hot runner systems, ideally within medical device manufacturing or another highly regulated sector.
Key Responsibilities
<ul>
<li>Support the full lifecycle of injection mould tools, from design review and manufacture through to validation and production release.</li>
<li>Troubleshoot tooling and process-related issues, identifying root causes and implementing robust corrective actions.</li>
<li>Lead and support tooling trials, first-off inspections, and tool validation activities (IQ/OQ/PQ where applicable).</li>
<li>Lead technical development and introduction of injection mould tooling for new product launches.</li>
<li>Work closely with production, quality, and process engineering teams to ensure tools perform reliably in a high-volume environment.</li>
<li>Provide technical support to customers, including participation in technical reviews, trials, and problem resolution meetings.</li>
<li>Drive continuous improvement initiatives related to tooling performance, cycle time, quality, and cost.</li>
<li>Maintain accurate tooling documentation, validation reports, and change records.</li>
<li>Collaborate with vendors and subcontractors to ensure tooling quality and timelines.</li>
<li>Ensure tooling activities comply with company procedures, quality standards, and health &amp; safety requirements.</li>
</ul>
Qualifications &amp; Experience
<ul>
<li>Formal engineering qualification or time-served toolmaking background is an advantage.</li>
<li>Strong knowledge of injection moulding processes, materials, and tooling principles.</li>
<li>Proven experience with toolmaking issues such as wear, venting, gating, cooling, flash, and dimensional variation.</li>
<li>Experience with tooling validation and production handover.</li>
<li>Hands-on, structured, and analytical approach to problem-solving.</li>
<li>Experience in high-volume or automotive/medical/packaging injection moulding environments is desirable.</li>
<li>Knowledge of continuous improvement tools (e.g. FMEA, SPC, 8D) is desirable.</li>
<li>Strong customer-facing skills, with the ability to communicate technical information clearly and professionally.</li>
<li>Self-motivated, practical, and results-driven, with the ability to stay calm and effective under pressure.</li>
<li>Excellent attention to detail and documentation skills.</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 further information on this role in please contact on Gavin Moran on 087 4108620 or connect@hero.ie 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

Job Details

Senior Quality Systems Specialist