Quality Assurance Engineer, Intermediate
Abbott · Ireland - Clonmel ·
- Category
- QA
- Experience
- 2+ years
JOB DESCRIPTION:
Abbott Ireland Vascular Division Clonmel
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education.
Our broad line of vascular devices–which includes vessel closure, endovascular and coronary technologies–are used to treat vessel diseases of the heart, carotid arteries and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions.
*Please note any offer of employment for this position is conditional upon the successful completion of a pre-employment medical examination, including drug and alcohol screening, conducted by a medical practitioner designated by the Company.
Purpose of the Role
Join a dynamic and high-impact role at the intersection of manufacturing, quality, and product development. As a Quality Assurance Engineer, you will play a critical part in ensuring the delivery of high-quality, compliant products to customers while driving continuous improvement across manufacturing operations.
This is a highly varied role, offering exposure to audits, CAPA, major projects, compliance standards, and new product introductions, ideal for someone who enjoys working across multiple areas and making a visible impact.
What You’ll Do
- Drive Quality & Compliance Excellence
Identify and resolve manufacturing issues (scrap, non-conformances, complaints) using structured root cause analysis, ensuring robust and sustainable CAPA implementation. - Own CAPA & Audit Activity
Lead and support CAPA processes, audit preparation, and audit responses, ensuring inspection readiness at all times. - Ensure Regulatory & ISO Compliance
Review processes, documentation, and project work to ensure alignment with ISO and regulatory standards, embedding compliance into all activities. - Support New Product Introductions (NPI)
Collaborate with cross-functional teams on new product launches, ensuring quality is built in from development through to commercialisation. - Contribute to Major Projects
Play a key role in large-scale projects, including compliance initiatives, process optimisation, and structured project rollouts. - Drive Continuous Improvement (CIP) Lead or contribute to continuous improvement projects using data-driven methodologies, Lean principles, and Six Sigma tools to reduce variation, improve process capability, and enhance operational performance.
- Use Data to Optimise Processes
Leverage process monitoring systems to identify critical control points and improve manufacturing capability. - Support Product & Process Development
Contribute to quality plans, specifications, risk assessments, and FMEA to ensure robust product design and manufacturing processes. - Validation & Technical Support
Participate in validation activities, including protocol/report writing and execution. - Enhance Customer Outcomes
Support Field Discrepancy Notification (FDN) investigations, ensuring customer feedback drives meaningful improvements. - Build Expertise
Develop strong capability in quality tools and methodologies while contributing to training and knowledge sharing.
What We’re Looking For
Education & Experience
- NFQ Level 7 qualification (or equivalent, full award) in Engineering, Science, or related field
- Minimum 2+ years’ relevant experience in a manufacturing or regulated environment
- Experience in CAPA, audits, project work, and/or new product introduction is highly desirable
Skills & Competencies
Technical & Business Knowledge
- Strong working knowledge of quality systems, processes, and procedures
- Experience operating in a regulated environment (e.g., ISO standards, GMP)
- Ability to review work to ensure compliance with regulatory and ISO requirements
- Understanding of cross-functional business operations
Cognitive Skills
- Solves problems of moderate scope using structured approaches
- Applies judgment within defined procedures
- Understands the impact of technical decisions on quality, compliance, and operations
Influence & Leadership
- Builds strong internal and external relationships
- May lead or contribute to project teams, CIP initiatives, or NPI activities
- Mentors or supports junior engineers
- Able to influence peers and first-line management
Planning & Organisation
- Effectively plans and prioritises work to meet project and production timelines
- Comfortable managing multiple priorities in a varied, fast-paced environment
Decision Making
- Makes decisions within defined frameworks and procedures
- Understands how decisions can impact timelines, resources, and compliance
Supervision
Received:
- Works under general supervision with a high level of autonomy
Provided:
- May guide and support junior staff
- May contribute to performance feedback and development activities
Why This Role Stands Out
- Highly varied position with exposure to manufacturing, audits, compliance, and product development
- Opportunity to apply and further develop Lean Six Sigma and continuous improvement expertise
- Opportunity to work on major projects, CIP initiatives, and new product launches
- Build expertise in CAPA, audits, validation, and ISO/regulatory standards
- Work in a collaborative, quality-driven environment
- Strong opportunities for career progression and development
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Abbott in Ireland | Benefits
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The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.