Quality Systems Engineer

CareerWise Recruitment; Waterford; On-site; EUR 65,000 - 95,000; Full time

Job summary

CareerWise Recruitment is seeking a Quality Systems Engineer for a leading pharmaceutical company in Waterford on a 12-month contract. You will drive digital transformation of quality processes, moving from paper-based systems to AI-enabled data analytics and integrated quality systems, partnering with Production and Quality teams to enable Right First-Time delivery.

The role requires a scientific degree and 3–5 years GMP experience, with a track record in CI projects, data-driven improvement,

Qualifications

• Degree qualification in a scientific field.
• 3–5 years' experience in GMP pharmaceutical manufacturing.
• Experience leading or facilitating Continuous Improvement projects.
• Experience using quality and performance data to identify trends.
• Knowledge of root-cause analysis and problem-solving methodologies.
• Strong understanding of Quality Management principles.
• Proactive approach with interest in digital transformation, AI and data-driven solutions.
• Commitment to quality and Right First-Time philosophy.

Responsibilities

• Lead and facilitate Continuous Improvement projects across Quality and Production.
• Identify opportunities for process optimisation and quality improvement with cross-functional teams.
• Monitor and analyse quality metrics and performance data to identify trends, risks and improvement opportunities.
• Support quality investigations using structured problem-solving and root-cause analysis techniques.
• Define and implement corrective and preventive actions.
• Support the introduction and adoption of new quality systems, digital tools and technologies.
• Contribute to the digital transformation of Quality processes, including transition away from paper-based systems.
• Explore and support AI and data-driven solutions to improve decision-making and process performance.
• Measure effectiveness and sustainability of improvement initiatives and identify remediation.
• Maintain accurate records of CI activities and communicate progress to stakeholders.
• Share best practices and promote Continuous Improvement across the organisation.
• Act as trusted advisor to Production and Quality on process improvement and quality management.
• Champion the Right First-Time principle across project execution.
• Operate in accordance with SMS 2.0 CI Specialist role standards.

Skills

Continuous Improvement

Root Cause Analysis

Quality Management

Data Analytics

AI & Digital Tools

Proactive Improvement

Quality Assurance

Education

Science degree

Job description

Job Description

A Quality Systems Engineer is required for a leading pharmaceutical Company based in Waterford . This is a 12-month contracting position. If you are interested in transitioning the clients Quality system from paper-based processes to digital solutions, while exploring the use of AI-driven tools and data analytics then this is the position for you !!!

THE ROLE

• Lead and facilitate Continuous Improvement projects across Quality and Production.
• Work with cross-functional teams to identify opportunities for process optimisation and quality improvement.
• Monitor and analyse quality metrics and performance data to identify trends, risks and improvement opportunities.
• Support quality investigations, applying structured problem-solving and root-cause analysis techniques.
• Define and implement appropriate corrective and preventive actions.
• Support the introduction and adoption of new quality systems, digital tools and technologies.
• Contribute to the digital transformation of Quality processes, including the transition away from paper-based systems.
• Explore and support the implementation of AI and data-driven solutions to improve decision-making and process performance.
• Measure the effectiveness and sustainability of improvement initiatives and identify further remediation where required.
• Maintain accurate records of CI activities and communicate progress, outcomes and benefits to key stakeholders.
• Share best practices and promote the benefits of Continuous Improvement across the organisation.
• Act as a trusted advisor to Production and Quality teams on process improvement and quality management best practice.
• Champion the Right First-Time principle across project execution and delivery.
• Operate in accordance with the SMS 2.0 CI Specialist role definition and standards.

Requirements

• Degree Qualification in a Scientific background
• 3-5 years experience within a GMP manufacturing / pharmaceutical company
• Experience leading or facilitating Continuous Improvement projects.
• Experience using quality and performance data to identify trends and improvement opportunities.
• Knowledge of structured root-cause analysis and problem-solving methodologies.
• A strong understanding of Quality Management principles.
• A proactive approach to identifying and delivering improvements.
• An interest in digital transformation, AI and data-driven solutions.
• A strong commitment to quality and the Right First-Time philosophy