Quality Engineer

QUALITY ENGINEER Department: Quality

Reports to: Quality Systems Lead

Job PurposeEnsure products meet approved specifications and that manufacturing activities comply with cGMP, applicable regulatory requirements and established quality standards.

Key Responsibilities

• Coordinate and maintain assigned elements of the Quality Management System (QMS).
• Participate in internal, external and supplier audits.
• Investigate nonconformances and customer complaints, supporting root cause analysis and CAPA implementation.
• Monitor CAPA progress, closure and effectiveness.
• Track quality metrics and prepare reports for management review.
• Provide quality and compliance training to personnel.
• Support validation activities, risk assessments and continuous improvement initiatives.
• Review batch records and documentation, and support authorised product release and disposition.
• Perform or support incoming, in-process and final product inspections and testing.
• Manage supplier quality issues and ensure compliance with approved specifications.
• Maintain accurate quality documentation and training records.
• Promote a strong quality culture, right-first-time execution and EHS compliance.

Qualifications and Experience

• Degree in Science, Engineering, Quality or a related discipline.
• At least two years’ experience in a regulated manufacturing quality system, preferably medical device or combination-product manufacturing.
• Knowledge of cGMP and quality standards such as ISO 9001, ISO 13485 and FDA 21 CFR Part 820 is desirable.
• Experience in CAPA, investigations, audits, validation and risk management is advantageous.
• Green Belt certification or industrial statistical knowledge is desirable.
• Experience in injection moulding or tooling is an advantage.

Key Skills and Competencies

• Strong analytical, problem-solving and investigation skills.
• Excellent attention to detail and documentation practices.
• Ability to work independently and take ownership of quality issues.
• Effective communication, training and cross-functional collaboration.
• Commitment to regulatory compliance, product quality, safety and continuous improvement.

EHS Responsibilities Comply with EHS policies, use required PPE, report incidents and near misses, complete mandatory training, and actively support a safe working environment.