Quality Systems Engineer

Careerwise Recruitment; Waterford; On-site; EUR 60,000 - 90,000; Full time

Job summary

Careerwise Recruitment is seeking a Quality Systems Engineer for a leading pharmaceutical company in Waterford. The role is a 12-month contracting position focusing on transitioning quality processes from paper to digital systems, including AI-driven analytics.

You will lead CI projects, collaborate with production and quality teams, analyse data for trends, and implement corrective actions to sustain improvements.

Qualifications

• Degree in a scientific field (e.g., chemistry, biology, or related) required.
• 3–5 years in GMP manufacturing/pharma environment with CI experience.
• Experience using data to identify trends and drive improvements.
• Knowledge of structured problem solving and root cause analysis.
• Understanding of Quality Management principles and Right First-Time philosophy.

Responsibilities

• Lead and facilitate Continuous Improvement projects across Quality and Production.
• Identify opportunities for process optimisation and quality improvements with cross-functional teams.
• Monitor quality metrics and performance data to spot trends and risks.
• Support investigations with structured problem-solving and corrective actions.
• Champion digital tools and AI-driven solutions to improve decisions and performance.

Skills

Continuous Improvement

Data analytics

Root cause analysis

Quality management

AI and digital transformation

Proactive mindset

Cross-functional collaboration

Education

Science degree

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 background3-5 years experience within a GMP manufacturing / pharmaceutical companyExperience 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