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Assembly Tech

Quality Control Team Lead
Location: Little Island, Cork, Ireland
Contract: Fixed-term contract
Contract End Date: 5 December 2027
Job Function: Quality
Job Subfunction: Quality Control
Industry: Pharmaceutical / Life Sciences
Position: 1
About the Role
We are seeking an experienced Quality Control / Compliance Analyst – QA to join a pharmaceutical manufacturing operation in Little Island, Cork.
The successful candidate will play a key role in maintaining and improving quality and compliance standards, while supporting the development and performance of the Quality Control team. This is an excellent opportunity for an experienced quality professional to contribute to a highly regulated pharmaceutical environment.
Key Responsibilities
Implement and maintain methods and procedures for inspection, testing and evaluation.
Mentor, train and supervise Quality Control staff, supporting their professional development and performance.
Evaluate team performance and identify opportunities for growth and improvement.
Communicate departmental objectives, performance metrics and quality expectations to the Quality Control team.
Support the implementation of changes to production methods, tooling, equipment, space allocation, workforce utilisation and production schedules where required to maintain or improve quality compliance.
Ensure existing products continue to meet applicable quality standards and support the establishment of initial and ongoing compliance requirements.
Supervise the timely investigation and evaluation of product complaints and returned products.
Initiate and support audits to verify that appropriate corrective actions are identified, implemented and completed promptly.
Monitor and communicate quality metrics and systems used to measure and drive improvements in product and system quality and customer satisfaction.
Provide input into Quality Control reports, requirements and documentation in response to proposals, quotations and other business opportunities.
Contribute to the budget planning process.
Identify and implement cost-control initiatives to support operational efficiency and reduce unnecessary expenditure.
Work collaboratively with relevant stakeholders to ensure a strong culture of quality, compliance and continuous improvement.
Requirements
University/Bachelor’s degree or equivalent qualification.
Typically 6–8 years' relevant work experience within quality, quality control, compliance or a related technical environment.
Experience within a regulated pharmaceutical, manufacturing or life sciences environment would be highly advantageous.
Strong knowledge of quality control principles, inspection, testing and evaluation.
Experience with audits, investigations, corrective actions and quality improvement initiatives.
Previous experience mentoring, training or supervising Quality Control personnel.
Strong analytical, organisational and problem-solving skills.
Excellent communication and stakeholder-management abilities.
Ability to work effectively in a structured, highly regulated environment.
A strong focus on compliance, quality standards and continuous improvement.
What You'll Be Doing
This role combines technical quality expertise with team leadership and continuous improvement. You will help ensure that quality systems and processes remain effective and compliant while supporting the Quality Control team and contributing to improvements in product quality, customer satisfaction and operational efficiency.
Location
Little Island, Cork, Ireland – T45 P663
If you are an experienced Quality professional looking for an opportunity to contribute to a pharmaceutical quality environment in Cork, we would be interested in hearing from you.

Quality Control / Compliance Analyst – QA

Senior NPD Program Manager Galway | Permanent, Full-Time |&nbsp;
HERO Recruitment is partnering with a global medical device contract development and manufacturing company to hire a Senior NPD Program Manager for its Galway site. Reporting to the NPD Director, you will lead customer development programmes for Class II and Class III medical devices from concept through to commercial, acting as the main point of contact for the customer throughout.
The role
<ul dir="ltr">
<li>Own the customer relationship on assigned programmes, leading meetings, technical reviews and project updates.</li>
<li>Lead cross-functional teams through all phases of development, including design reviews, verification, validation and design transfer.</li>
<li>Manage project scope, schedule, budget, resources and risk, with clear reporting to customers and internal stakeholders.</li>
<li>Develop and negotiate Statements of Work, and manage scope changes through delivery.</li>
<li>Support the Business Development team with opportunity assessments, proposals and customer visits.</li>
<li>Ensure compliance with FDA Design Controls and ISO 13485.</li>
</ul>
What you will bring
<ul dir="ltr">
<li>A degree in Engineering or a related technical discipline.</li>
<li>10+ years' experience in the medical device industry, including Class II and Class III device development.</li>
<li>Proven expertise in catheter-based devices (balloon catheter and/or braided shaft technologies).</li>
<li>Significant customer-facing experience, including technical presentations and stakeholder management.</li>
<li>Experience leading design verification and validation activities.</li>
<li>A track record of managing project scope, budgets and resources, and of developing Statements of Work.</li>
<li>CDMO experience and a PMP or equivalent certification are an advantage.</li>
</ul>
To apply or find out more, contact Dee Curley at HERO Recruitment on <a href="mailto:dee@hero.ie" target="_blank" rel="noopener">dee@hero.ie</a> or 086 7902191.

Program Manager - NPD 

Senior NPD Engineer 
Location: Galway, Ireland 
Reports To: Director, NPD 
Type: Full-time
Our client, a leading medical device manufacturer, is seeking a Senior NPD Engineer to provide technical leadership for development programs throughout the NPD lifecycle. Acting as technical lead, you'll be responsible for engineering execution and technical decision-making, ensuring products are developed in accordance with customer, regulatory, quality, and manufacturing requirements. You'll serve as the primary technical interface with customers, leading technical discussions, design reviews, and problem-solving activities, while partnering with the Program Manager on project planning, budgeting, and risk management. The role also provides leadership, coaching, and mentoring to engineers and technicians, and may carry direct people management responsibility.
Key Responsibilities
<ul dir="ltr">
<li>Lead the technical execution of product development programs from feasibility through manufacturing transfer.</li>
<li>Act as the primary technical interface with customers, building strong relationships and providing technical leadership throughout the development process.</li>
<li>Lead technical reviews, design reviews, risk assessments, and problem-solving activities with customers and internal teams.</li>
<li>Own technical strategy, design decisions, and engineering execution for assigned projects.</li>
<li>Ensure products and associated processes are developed in accordance with customer requirements, Design Controls, regulatory standards, and business objectives.</li>
<li>Partner with Program Managers on project planning, budgeting, resource allocation, and risk management.</li>
<li>Identify, assess, and mitigate technical risks throughout the product development lifecycle.</li>
<li>Drive development activities through verification, validation, design transfer, and commercialisation.</li>
<li>Collaborate with customers and internal stakeholders (Manufacturing, Quality, Supply Chain) to achieve successful project outcomes.</li>
<li>Support manufacturing scale-up, product transfer, and post-commercialisation activities.</li>
<li>Provide leadership, coaching, and technical guidance to engineers and technicians; may have direct people management responsibility.</li>
<li>Maintain accurate technical documentation and development records throughout all stages of product development.</li>
</ul>
Qualifications &amp; Experience
<ul dir="ltr">
<li>Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Polymer Engineering, or a related discipline.</li>
<li>Minimum 7 years of medical device product development experience.</li>
<li>Demonstrated experience leading development projects throughout the product development lifecycle.</li>
<li>Experience working within Design Control and regulated medical device environments.</li>
<li>Proven customer-facing experience with responsibility for technical discussions and project leadership.</li>
<li>Experience leading, mentoring, or managing engineers and technical teams.</li>
<li>Working knowledge of Design Controls, Risk Management, Verification &amp; Validation, and Design Transfer.</li>
<li>Knowledge of applicable medical device regulations and standards, including ISO 13485 and FDA requirements.</li>
<li>Experience with catheter-based, balloon catheter, or delivery system technologies is an advantage.</li>
</ul>
For further information on this role please contact Gavin Moran on 087 4108620 or <a href="mailto:connect@hero.ie" target="_blank" rel="noopener">connect@hero.ie</a> Check out all our open jobs on our HERO Recruitment website &#150; <a href="https://www.hero.ie/" target="_blank" rel="noopener">https://www.hero.ie/</a> Please Note: Under its obligation under the 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 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 your application.

Senior NPD Engineer

Quality Lead&nbsp;
Our client, a leading medical device manufacturer, is seeking a Validation Supervisor to lead a site-based team of Validation Quality Engineers. This role is accountable for the effective planning, coordination, and execution of equipment and process validation activities supporting new product introductions, change control, and strategic initiatives. You'll partner closely with Design Assurance, Engineering, Manufacturing, and Quality teams to ensure validation activities are executed in compliance with the Quality Management System and applicable regulatory requirements, playing a critical role in maintaining a compliant validated state.
Key Responsibilities
<ul>
<li>Lead and supervise a team of Validation Quality Engineers, providing coaching, mentoring, and performance guidance.</li>
<li>Plan and coordinate execution of equipment, process, and test method validations supporting new product development, change control, and strategic initiatives.</li>
<li>Ensure validation activities are performed in accordance with internal procedures, regulatory requirements, and industry best practices.</li>
<li>Review and approve validation documentation, including validation plans, risk assessments, protocols, reports, and deviation or exception documentation.</li>
<li>Allocate resources and manage timelines to support project schedules and operational priorities.</li>
<li>Act as site validation liaison with Design Assurance, R&amp;D, Engineering, Manufacturing Operations, Supply Chain, and Quality functions.</li>
<li>Support compliance activities including internal audits, inspections, and CAPA processes.</li>
<li>Identify and drive continuous improvement opportunities related to validation processes, standard work, and compliance practices.</li>
<li>Apply problem-solving, critical thinking, and risk-based decision-making in a dynamic manufacturing environment.</li>
<li>Communicate complex technical information clearly to diverse stakeholders, including senior leadership.</li>
</ul>
Qualifications &amp; Experience
<ul>
<li>Bachelor's degree in Engineering, Science, or a related discipline, or equivalent experience.</li>
<li>8&#150;12 years' experience in validation, quality engineering, or a related role within a regulated industry.</li>
<li>Demonstrated experience working in medical device, pharmaceutical, or similarly regulated manufacturing environments.</li>
<li>Prior experience leading or supervising technical or quality teams is required.</li>
<li>Strong working knowledge of ISO 13485, FDA 21 CFR Parts 820 and 11, and related regulatory standards.</li>
<li>Experience with statistical analysis and validation tools.</li>
<li>Demonstrated experience supporting audits and regulatory inspections.</li>
<li>Certified Quality Engineer (CQE) or equivalent professional certification is an advantage.</li>
</ul>
For further information on this role please contact Gavin Moran on 087 4108620 or connect@hero.ie
Check out all our open jobs on our HERO Recruitment website &#150; https://www.hero.ie/
Please Note: Under its obligation under the 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 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 your application.

Quality Lead 

Summary
The Senior Engineer, Moulding provides technical leadership for injection moulded components, tooling, and manufacturing processes across global operations. The role partners with Engineering, Operations, Research and Development, New Product Development, Quality, Supply Chain, and external suppliers to support product and process development, validation, commercialization, and continuous improvement. The position leads complex technical projects, drives robust moulding solutions, manages supplier and tooling activities, and ensures the successful introduction and optimization of validated manufacturing processes.
Responsibilities
<ul>
<li>Lead and influence cross-functional and geographically dispersed teams to achieve project objectives and business priorities.</li>
<li>Manage technical projects from concept through implementation, including scope, schedules, budgets, risks, resources, and deliverables.</li>
<li>Partner with stakeholders across Engineering, Operations, Quality, Supply Chain, Research and Development, and New Product Development to support product lifecycle activities.</li>
<li>Provide technical expertise in injection moulding, tooling, component development, and process validation.</li>
<li>Lead supplier identification, selection, qualification, and ongoing performance management activities.</li>
<li>Develop and maintain component specifications, technical drawings, models, process documentation, and validation records.</li>
<li>Plan and execute prototype, pilot, and proof-of-concept activities to evaluate designs and manufacturing approaches.</li>
<li>Apply scientific and data-driven methodologies, including design of experiments and process optimization techniques, to improve process capability and performance.</li>
<li>Oversee mould design, build, qualification, and implementation activities.</li>
<li>Assess impacts of component changes on manufacturing systems and coordinate required equipment modifications and validations.</li>
<li>Support the introduction of new products, technologies, and process improvements into manufacturing environments.</li>
<li>Monitor project performance using defined metrics and implement corrective actions as needed.</li>
<li>Maintain awareness of industry, regulatory, and technology developments relevant to the role.</li>
<li>Communicate effectively through verbal, written, and presentation-based methods.</li>
<li>Use computer systems and standard business software to perform daily responsibilities.</li>
<li>Participate in meetings, project reviews, manufacturing assessments, and collaborative activities.</li>
<li>Travel domestically and internationally as required to support projects, suppliers, and business operations.</li>
<li>Perform occasional physical activities associated with engineering and manufacturing environments, including walking, bending, climbing, and lifting materials or equipment up to approximately 15 pounds.</li>
<li>Provide schedule flexibility when required to support critical project implementation activities.</li>
</ul>
Essential Functions of the Role
<ul>
<li>Communicate effectively via email, phone, and virtual platforms.</li>
<li>Collaborate across departments to support organizational goals.</li>
<li>Ensure data accuracy and confidentiality in compliance with company and legal standards.</li>
<li>Lead or support special projects aligned with departmental objectives.</li>
<li>Travel frequently, including overnight and occasional weekend travel.</li>
<li>Occasional lifting of materials up to 15 pounds may be required.</li>
<li>Communicate with supervisors and team members to coordinate workflow.</li>
<li>Support product development and design assurance.</li>
<li>Participating in cross-functional project teams.</li>
<li>Ensuring adherence to regulatory standards (e.g., EU MDR, FDA).</li>
<li>Education &amp; Work Requirements</li>
<li>Bachelor&#146;s Degree with 5-8 years of related experience</li>
</ul>
Education &amp; Work Preferences
<ul>
<li>Bachelor&#146;s degree in Engineering or a related technical discipline.</li>
<li>Minimum of 5 years of experience in injection moulding, tooling, process development, manufacturing engineering, or a related field.</li>
<li>Minimum of 3 years of experience leading or managing technical projects.</li>
<li>Demonstrated expertise in injection moulding processes, tooling, qualification, and validation activities.</li>
<li>Experience with CAD software and technical documentation development.</li>
<li>Knowledge of project management principles, supplier management, budgeting, and cost control.</li>
<li>Strong analytical, problem-solving, technical writing, and communication skills.</li>
<li>Proficiency with Microsoft Office and standard business applications.</li>
<li>Advanced degree in Engineering or a related discipline.</li>
<li>Hands-on experience in mould making, process development, and high-volume manufacturing environments.</li>
<li>Experience with scientific moulding methodologies, design of experiments (DOE), design for manufacturability (DFM), and statistical analysis tools.</li>
<li>Proficiency with 3D CAD applications, including SolidWorks.</li>
<li>Experience working with highly automated manufacturing systems and global cross-functional teams.</li>
</ul>

Job Details

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Assembly Tech

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