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Quality Engineer
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Tommy McKeown
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Contract
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
Comply with EHS policies, use required PPE, report incidents and near misses, complete mandatory training, and actively support a safe working environment.
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.
- 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.
- 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.
Comply with EHS policies, use required PPE, report incidents and near misses, complete mandatory training, and actively support a safe working environment.
