Quality Engineer

Quality Engineer

Department Quality Assurance
Reports To Quality Manager

Position Summary

We are seeking a motivated and experienced Quality Engineer to join our Quality team. The successful candidate will provide quality engineering support across both operational and project activities, ensuring compliance with regulatory requirements, quality standards, and company procedures. This role requires a balanced mix of validation expertise, project experience, and operational quality support within a regulated manufacturing environment.

Key Responsibilities

Quality Operations

• Provide day-to-day quality engineering support to manufacturing operations.
• Investigate quality events, deviations, non-conformances, and customer complaints.
• Support root cause analysis and implementation of effective corrective and preventive actions (CAPA).
• Review and approve quality documentation, including procedures, work instructions, and batch records where applicable.
• Support change control activities and assess quality impact.
• Monitor quality metrics and identify opportunities for continuous improvement.

Validation & Qualification

• Develop, review, and execute validation documentation, including:
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Process Validation
  • Cleaning Validation (where applicable)
• Support equipment, utility, and process qualification activities.
• Ensure validation activities comply with regulatory and company requirements.

Project Support

• Act as the Quality representative on cross-functional project teams.
• Support new product introductions, technology transfers, and facility or equipment upgrades.
• Review and approve project documentation from a quality perspective.
• Ensure quality requirements are incorporated throughout the project lifecycle.
• Participate in project risk assessments and design reviews.

Compliance & Continuous Improvement

• Ensure compliance with applicable GMP, ISO, and regulatory requirements.
• Support internal and external audits and regulatory inspections.
• Participate in continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.
• Promote a quality culture across the organisation.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, or a related discipline.
• Minimum of 3–5 years' experience in a regulated manufacturing environment (pharmaceutical, medical device, biotechnology, or similar).
• Experience in both quality operations and validation activities.
• Previous project experience supporting new equipment, process improvements, or capital projects is highly desirable.

Knowledge & Experience

• Strong understanding of GMP and quality management systems.
• Experience with validation lifecycle principles.
• Knowledge of CAPA, deviations, change control, and risk management.
• Experience with internal and external audits.
• Familiarity with regulatory requirements, including FDA, EU GMP, ISO 13485, or ISO 9001 (as applicable).
• Strong documentation and technical writing skills.

Key Competencies

• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management.
• Ability to work effectively in cross-functional teams.
• High attention to detail and commitment to quality.
• Strong planning and organisational skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Continuous improvement mindset.

Desirable Skills

• Experience with statistical analysis and quality tools.
• Lean Six Sigma Green Belt (or equivalent).
• Experience supporting digital quality systems (eQMS).
• Knowledge of data integrity and electronic quality management systems.