Job Details
Quality Engineer
PRIMARY FUNCTION:
The role will involve ensuring that all quality investigations are conducted in accordance with all relevant standards and requirements. Responsible to lead and conduct the internal assessment program in accordance with relevant procedures.
MAJOR DUTIES AND RESPONSIBILITIES:
- Conduct quality investigations using applicable tools and techniques to drive to root cause.
- Responsible in completing and assigning CAPA’s as required.
- Managing the track wise database while ensuring all applicable data is completed correctly.
- Conducting internal and external assessments to ensure the QMS (Quality Management System) is in compliance with corporate policy requirements.
- Ensure all actions are appropriately assigned, followed up, closed out and verified within the agreed timeframe.
- Compilation of weekly, monthly and quarterly reports as required.
- Oversee change requests process and ensuring it fully complies with all relevant requirements.
- Developing and championing continuous improvement programmes.
- Reviewing quality standards such as ISO 13485-2003, FDA QSR and MDD 93/42 as required.
- Ensuring all team members is fully aware of the quality requirements by providing the necessary training where relevant.
- Assisting in and performing ad-hoc duties as required.
KNOWLEDGE AND EDUCATION:
Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts, and principles.
- Minimum education qualification: Diploma in Quality / Engineering related discipline.
- Experience: 2-4 years working in similar role
- Good communication and computer skills
Desirable requirements:
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