Job Title: Quality Engineer II (Complaints)Reports to: Senior Quality Engineer &#8211; ComplaintsContract: 12-month contract (hybrid)OverviewAn opportunity is available for a Quality Engineer to join a complaints investigation team within a cardiovascular medical device function. The role focuses on supporting investigations, ensuring high-quality complaint handling, and contributing to continuous improvement initiatives within a growing business area.Purpose of the RoleProvide Quality Engineering support to the complaint investigation process, ensuring high standards in investigation quality, regulatory compliance, and adherence to quality systems, with a strong focus on patient safety and product quality.Key ResponsibilitiesReview and approve complaint investigations within a global complaints management systemConduct complaint investigations, including lab testing of returned devices where requiredPerform root cause analysis and define appropriate investigation pathwaysAnalyse product and process performance using data analytics toolsPrepare and present complaint trend data to relevant review forumsDrive continuous improvement in investigation methods and processesMake decisions on escalation pathways and work independently when requiredEnsure compliance with all applicable quality system regulationsCollaborate with cross-functional teams including Quality, R&amp;D, Operations, and Field SupportRequirementsLevel 8 qualification in a STEM discipline with 2&#8211;3 years&#8217; relevant experienceStrong problem-solving, process improvement, or project management skillsAbility to take initiative and drive improvementsKnowledge of product design, manufacturing, or clinical use (advantageous)Strong analytical, communication, and organisational skillsAbility to work both independently and within a teamExperience with imaging review (advantageous)Willingness to complete required health and safety training for handling returned products

Quality Engineer II

Quality Technician II &#150;
Complaints Investigation Site
4 days onsite
15 month contract&nbsp;
Job purpose:
Part of core team to analysed and investigate customer complaints, including responding to and escalating, as appropriate, quality related issues and implementing corrective and preventive actions to eliminate repeat instances.
Key Responsibilities:
<ul>
<li>Perform complaint product investigations.</li>
<li>Clear and concise communication of complex ideas.</li>
<li>Engages with different functions and departments. Collaborates cross-functionally and across departments to achieve goals</li>
<li>Ensures compliance with all applicable regulatory standards, as well as BSC procedures and Work Instructions.</li>
<li>Perform documentation review, including Device History Record, Risk documentation, and Labeling review, amongst others.</li>
<li>Performing product defect analysis. Includes performing product dimensional, functional, and/or visual testing to confirm failure modes.</li>
<li>Contribute and/or support NCEP activities</li>
<li>Identify areas of improvement and participate in continuous improvement projects.</li>
<li>Contributing to problem solving and continuous projects.</li>
<li>Supports additional tasks required in the complaints laboratory (including decontamination</li>
<li>Decision making ability coupled with the ability to work on ones own initiative and with moderate supervision is required.</li>
<li>Good interpersonal skills and organization skills, with excellent attention to detail.</li>
<li>Communicates any concerns about work process regarding environmental impact, health or safety issues to their manager.</li>
</ul>
Required Qualifications
<ul>
<li>Diploma or Degree - Level 6 or 8</li>
<li>2-3 years experience in Quality or Operations role</li>
<li>Hep B Vaccination Required (If successful)</li>
</ul>

Quality Technician II 

Research and Development Engineer Galway, IrelandCompany OverviewOur client is a prominent player in the medical device industry, committed to enhancing healthcare globally.Position OverviewWe are seeking a proficient Research and Development Engineer on a contractor basis to support our Shelf-Life Extension initiative for several commercial products. The ideal candidate will possess Design Control expertise, hands-on experience with Design Verification, and a solid grasp of technical writing. Additionally, familiarity with material properties, ageing impacts, Product Specifications, Test Methods, and regulatory requirements is essential for this role.Key Responsibilities<ul><li>Collaborate closely with cross-functional teams to execute Shelf-Life Extension strategies for commercial products, ensuring compliance with regulatory standards and quality requirements.</li></ul><ul><li>Develop and execute Design Verification protocols and reports, meticulously documenting findings and ensuring alignment with product specifications.</li></ul><ul><li>Conduct thorough technical analyses to assess material properties, ageing effects, and potential risks associated with shelf-life extension.</li></ul><ul><li>Define and execute sample selection processes, considering factors such as sample size, unit rationale, and statistical analyses (variable vs attribute stats).</li></ul><ul><li>Work closely with Bill of Materials (BOMs), Process Plans, design prints, and design inputs/outputs to drive successful project outcomes.</li></ul><ul><li>Manage documentation processes, including regulatory submissions, design documentation, and risk management activities.</li></ul><ul><li>Collaborate with team members to ensure project milestones are met, escalating issues as needed and actively contributing to problem-solving efforts.</li></ul><ul><li>Demonstrate independence, initiative, and technical proficiency in navigating project complexities and challenges.</li></ul>Qualifications<ul><li>Bachelor's degree in Engineering or related field; advanced degree preferred.</li></ul><ul><li>Proven experience in Design Control within the medical device industry, with a focus on Shelf-Life Extension projects.</li></ul><ul><li>Strong familiarity with Design Verification methodologies, including protocol development, execution, and report writing.</li></ul><ul><li>Excellent technical writing skills, with the ability to communicate complex concepts clearly and effectively.</li></ul><ul><li>In-depth understanding of material properties, ageing processes, and their implications for product performance and shelf-life extension.</li></ul><ul><li>Knowledge of Product Specifications, Test Methods, and statistical analyses (sample selection, variable vs attribute stats).</li></ul><ul><li>Proficiency in interpreting and working with Bill of Materials (BOMs), Process Plans, design prints, and design inputs/outputs.</li></ul><ul><li>Familiarity with Risk Management processes and regulatory requirements (e.g., ISO 13485, FDA regulations).</li></ul><ul><li>Ability to work independently, seek guidance when necessary, and collaborate effectively within a team environment.</li></ul>

Research and Development Engineer

<h1>PROJECT MANAGER &#151; CONTRACT About the Role</h1>
The Project Manager will support New Product Development within the Coronary Therapies franchise.
The role will coordinate defined projects and workstreams across the Drug Eluting Therapies portfolio, helping drive schedule, action, risk, and issue management in a cross-functional environment.
<h2>About the Role</h2>
<ul>
<li>
Support delivery of defined projects and workstreams within Coronary Therapies.
</li>
<li>
Coordinate cross-functional activities to support project milestones and deliverables.
</li>
<li>
Work with functions including R&amp;D, Design Assurance, Regulatory, Operations, Supplier Quality, Supply Chain, Packaging, Process Development, and Clinical.
</li>
</ul>
<h2>Your Responsibilities Include</h2>
The Project Manager will manage assigned workstreams or small-to-medium complexity projects, ensuring clear plans, actions, risks, issues, and stakeholder updates are maintained.
<h3>Project / Program Management</h3>
<ul>
<li>
Develop and maintain project plans, schedules, action logs, risk/issue registers, and status updates.
</li>
<li>
Track priorities, dependencies, resource needs, and delivery constraints.
</li>
<li>
Identify, track, and escalate risks, issues, decisions, and technical challenges.
</li>
<li>
Drive execution by ensuring clear ownership of actions and deliverables.
</li>
<li>
Facilitate effective meetings, follow-ups, and project governance preparation.
</li>
<li>
Support decision-making by gathering inputs, documenting options, and escalating decisions as needed.
</li>
<li>
Work with project teams to resolve execution challenges and support practical solutions.
</li>
<li>
Track project milestones, costs, and progress, escalating concerns to PMO or functional leadership.
</li>
</ul>
<h3>Product / Compliance Management</h3>
<ul>
<li>
Support technical, quality, regulatory, and process discussions for assigned project activities.
</li>
<li>
Track compliance-related actions, updates, and deliverables.
</li>
<li>
Maintain risk visibility in line with project governance and quality processes.
</li>
<li>
Support compliance with applicable company policies, procedures, quality system requirements, and regulatory expectations.
</li>
</ul>
<h3>Process Management</h3>
<ul>
<li>
Apply PLCP lifecycle and project management practices to support high-quality project outcomes.
</li>
<li>
Maintain clear project records, actions, decisions, and status visibility.
</li>
</ul>
<h2>Key Competencies</h2>
<ul>
<li>
Execution Discipline
</li>
<li>
Communication
</li>
<li>
Planning and Organisation
</li>
<li>
Risk and Issue Escalation
</li>
<li>
Collaboration
</li>
<li>
Problem Solving
</li>
</ul>
<h2>What We&#146;re Looking For</h2>
<h3>Minimum Qualifications</h3>
<ul>
<li>
Bachelor&#146;s degree required, preferably in Engineering, Science, Business, or Project Management.
</li>
<li>
2+ years of relevant project coordination, project management, engineering, quality, operations, or product development experience.
</li>
<li>
Experience working in cross-functional teams and supporting project milestones, actions, and deliverables.
</li>
<li>
Able to work independently on assigned tasks with guidance from PMO or functional leadership.
</li>
<li>
Able to ramp quickly and become productive in a contract environment.
</li>
</ul>
<h3>Preferred Qualifications</h3>
<ul>
<li>
PMP certification.
</li>
<li>
Medical device, product development, or regulated industry experience.
</li>
<li>
Strong organisation, execution, communication, and stakeholder coordination skills.
</li>
</ul>

Project Manager

Senior Chemist
Location: Onsite
Contract Duration: 12 Months
Role Overview
We are seeking a highly motivated Analytical Scientist to perform laboratory testing and support analytical method development within a regulated environment. The successful candidate will play a key role in ensuring product quality, compliance, and continuous improvement initiatives.
Key Responsibilities
<ul>
<li>Perform analytical testing on drug and combination products using techniques such as Liquid and Gas Chromatography, spectroscopic methods, elution, and wet chemistry.</li>
<li>Develop and validate analytical test methods in line with regulatory requirements.</li>
<li>Lead and support laboratory investigations, ensuring timely closure and proper documentation.</li>
<li>Accurately interpret and report analytical results, including trending data and generating technical reports.</li>
<li>Collaborate with cross-functional teams including Quality, Supply Chain, Operations, Finance, and Engineering to ensure efficient and compliant processes.</li>
<li>Provide technical expertise for analytical instrumentation and methodologies, including troubleshooting as needed.</li>
<li>Drive continuous improvement initiatives to reduce testing lead times and achieve cost savings.</li>
<li>Independently plan and schedule work to meet project deadlines.</li>
<li>Support the training and onboarding of new team members.</li>
<li>Participate in internal and external audit programs.</li>
<li>Contribute to regulatory submissions and related documentation.</li>
</ul>
Requirements&nbsp; 
<ul>
<li style="font-family: Calibri; font-size: 11pt;">4+ years experience&nbsp;</li>
<li style="font-family: Calibri; font-size: 11pt;">Level 8 Degree in relevant field</li>
</ul>

Senior Chemist 

<h2>1. Job Purpose</h2>
Provide engineering support in the development of new equipment and processes, as well as the improvement of existing equipment and processes.
Define, or assist in defining, process and equipment requirements and specifications based on process requirements, applicable safety standards, regulatory requirements, and customer needs.
<h2>2. Key Responsibilities</h2>
<ul>
<li>
Perform project management activities for small to medium-scale projects involving new or existing equipment.
</li>
<li>
Assist in determining project budgets and resource requirements.
</li>
<li>
Evaluate, or assist in evaluating, technologies required to support project and business requirements.
</li>
<li>
Develop and present appropriate options and recommendations to management, customers, and key stakeholders.
</li>
<li>
Provide technical engineering support throughout projects and equipment/process activities.
</li>
<li>
Support and/or develop and execute equipment and process validation activities in accordance with applicable quality systems, procedures, and regulatory requirements.
</li>
<li>
Assist with the evaluation, selection, and negotiation of equipment suppliers.
</li>
<li>
Utilise appropriate project management tools, including User Requirement Specifications (URS), Microsoft Project, and other relevant tools, to successfully manage projects.
</li>
<li>
Develop and maintain the necessary equipment, process, and product knowledge to become a recognised local subject matter expert.
</li>
<li>
Measure and evaluate equipment efficiency, downtime, and performance, and assist in developing appropriate maintenance requirements.
</li>
<li>
Propose and implement improvement projects that enhance compliance, efficiency, yield, throughput, and overall equipment performance.
</li>
<li>
Investigate equipment- and process-related non-conformances, establish root causes, and implement effective corrective and preventive actions using applicable quality-system processes.
</li>
<li>
Work collaboratively with cross-functional teams and support day-to-day operational requirements.
</li>
<li>
Ensure effective and timely closure of quality-system documentation, including audit actions, non-conformances, CAPAs, and other relevant quality records.
</li>
<li>
Ensure appropriate safety and environmental requirements are incorporated into the purchase, installation, modification, and operation of new and existing equipment.
</li>
<li>
Promote a culture of continuous improvement, compliance, safety, and operational excellence.
</li>
</ul>
<h2>3. Education and Experience</h2>
<h3>Essential</h3>
<ul>
<li>
Relevant degree or equivalent qualification in Production Engineering, Manufacturing Engineering, Mechanical Engineering, or a related discipline.
</li>
</ul>
<h3>Desirable</h3>
<ul>
<li>
2&#150;4 years' experience in a relevant engineering role.
</li>
<li>
Previous experience within a GMP, pharmaceutical, biotechnology, or medical-device manufacturing environment.
</li>
<li>
Experience with equipment and process validation activities.
</li>
<li>
Experience in process development and optimisation.
</li>
<li>
Familiarity with applicable ISO and machinery safety standards.
</li>
<li>
Experience applying statistical and problem-solving methodologies, including Lean Six Sigma or equivalent techniques.
</li>
<li>
Familiarity with equipment validation within a regulated environment, including experience with FDA requirements, would be advantageous.
</li>
<li>
Experience with Statistical Process Control (SPC), process capability analysis, ANOVA, and Design of Experiments (DOE).
</li>
<li>
Ability to apply a scientific and structured approach to problem solving, combining analytical and experimental techniques to maximise productivity, quality, and yield.
</li>
</ul>
<h2>4. Skills and Attributes</h2>
<ul>
<li>
Ability to develop and maintain strong working relationships across the organisation.
</li>
<li>
Ability to motivate, influence, and lead others while working effectively as part of a team.
</li>
<li>
Ability to work independently and demonstrate initiative.
</li>
<li>
Strong project management, organisational, and communication skills.
</li>
<li>
Strong attention to detail and commitment to accuracy.
</li>
<li>
Ability to manage multiple priorities and deliver projects within agreed timelines.
</li>
<li>
Strong analytical and problem-solving capabilities.
</li>
<li>
Practical, hands-on approach to engineering and continuous improvement.
</li>
<li>
Commitment to quality, safety, compliance, and operational excellence.
</li>
</ul>

Job Details

Quality Engineer II