Job Overview
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We are seeking a highly skilled Quality Assurance Engineer to join our team. The successful candidate will be responsible for ensuring the day-to-day operation of our quality system is effective and compliant with regulatory requirements.
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Main Responsibilities
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* Coordinating assigned elements of the Quality System, ensuring full compliance by all relevant personnel.
* Performing Risk Assessments and associated Risk documentation.
* Assisting in the investigation and coordination of design control, validation, and change control related customer complaints/Non-Conformances.
* Reviewing and approving documents generated in Validation Management System (M-Files).
* Managing key site projects and liaising with internal and external stakeholders.
* Measuring performance of the Quality System and providing metrics for inclusion in management reviews.
* Ensuring all personnel are fully aware of quality requirements through training.
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Required Skills and Qualifications
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To be successful in this role, you will require:
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* Educated to degree or diploma level in an engineering, science, or quality-related discipline.
* Strong working knowledge of quality systems regulations, including IS 9001 and individual elements within the regulations.
* Proven Validation skills in a regulated environment.
* Risk management skills, including risk assessment and understanding of ISO standards.
* Excellent interpersonal and communication skills.
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Benefits
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This role offers excellent opportunities for professional growth and development in a dynamic and supportive environment.
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Others
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We offer a competitive salary and benefits package, as well as opportunities for career advancement and professional growth.
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