Quality Engineer (Medical Devices)

Manpower Staffing Services (Singapore) Pte Ltd| Date Posted: 11-May-2021
EA Licence No: 02C3423
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Job Nature:
Diploma, Bachelor's / Honours, Masters / PhD

Job Description

The Quality Engineer is responsible for the application and interpretation of the site/Business procedures to ensure consistency and compliance with Quality Systems. The Quality Engineer shall work with the Quality Technician team in quality operations related activities, including testing at In-coming, In-processes and out-going to ensure that products comply with quality standards, per specifications under cGMP and Quality System rules. The Quality Engineer will lead the analyzing of quality data and investigation analysis, deploying the appropriate statistical and analytical tools. The Quality Engineer may take the lead in root cause investigations for issues of moderate complexity.
  • Work with Quality Technician team in timely disposition of Non-conformities, including leading the investigation of block products and materials and work with process owners and subject matter experts in concession release criteria.
  • Reporting of defect trending to stakeholders.
  • Assist Lead/Senior Quality Engineer in preparation and presentation of standard reports (Quality figures and analysis results).
  • Execution of root-cause analysis on non-conformities and to initiate preventive and corrective actions. Ensures that corrective measures meet acceptable reliability /quality standards and that documentation is compliant with requirements.
  • Coordination and evaluation of analytical tests data.
  • Leading the coordination and investigation of Product Non Conformities with the usage of RCA tools.
  • Training of production personnel as trainer on inspection specifications in accordance to inspection specifications.
  • Plan, test and qualify quality-related software changes and updates.
  • Devices and implements methods and procedures for inspecting, testing and evaluating/verifying the quality characteristics of the products/processes.
  • Implementation of opportunities for improvement in regulations and maintenance of inspection documents.
  • Support product transfer activities as Quality function representative.
  • Creation of Inspection plan in SAP and leading the coordination and investigation of deviations with incoming materials.
  • Degree in the field of mechanical, Electrical, Bioengineering discipline, Quality Certification or equivalent.
  • At least 3 years of experience in quality role in a regulated environment
  • Quality Inspections techniques Analysis.
  • Quality Inspections techniques and experiences in handling measuring instruments.
  • Experience in using Quality Tools.
  • Comprehending Technical Drawings.
  • Experience in Cleaning and Hygiene Regulations

Teh Hui Tian, Zoe EA License No. 02C3423 Personnel Registration No. R2089915

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