Jobs

    Engineer II, Quality Operations CRM - Singapur, Singapore - BIOTRONIK

    BIOTRONIK
    BIOTRONIK Singapur, Singapore

    1 week ago

    Default job background
    Full time
    Description

    Engineer II, Quality Operations CRM

    As one of the world ́s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

    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 BIOTRONIK 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.

    Your Responsibilities

  • 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
  • Assist Lead/Senior Quality Engineer in preparation and presentation of standard reports (Quality figures, trending 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.
  • Implements methods and procedures for inspecting, testing and evaluating/verifying the quality characteristics of the products/processes.
  • On-site supervision of first series for new and modified processes in collaboration with other supporting functions Process engineers, MES team, and Risk Management group
  • 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.
  • Supporting/Leading Continuous improvement (CI) projects.
  • Act as Quality function representative in validation activities
  • Your Profile ​​​​​​​

  • Diploma with at least 5 years experience/Degree in the field of mechanical, Electrical, Bioengineering discipline, Quality Certification or equivalent
  • At least 3 years of experience in quality role in an regulated environment (eg: medical devices, component manufacturing, pharmaceutical industry) or prior work experience in a technical area with strong affinity for Quality Assurance
  • Quality Inspections techniques Analysis
  • Quality Inspections techniques and experiences in handling measuring instruments
  • Experience in using Quality Tools
  • Experience with SAP and MES preferred (Manufacturing Execution Systems))
  • Comprehending Technical Drawings
  • Experience in Cleaning and Hygiene Regulations
  • Preferred ISO 13485 Internal auditor / knowledge in FDA will be an advantage
  • Knowledge in process validation and computer system validation
  • Continuous Improvement (CI) Project experience
  • Project management/ transfer experience will be an advantage
  • What we offer

  • being encouraged to think and act entrepreneurially.
  • working in global teams and projects.
  • developing yourself professionally.


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