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Quality Engineer

3 weeks ago

Singapore BIOTRONIK Full time

Quality Engineer

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.

**Your Responsibilities**
- 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 e.g 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**
- Degree in the field of mechanical, Electrical, Bioengineering discipline, Quality Certification or equivalent
- At least two years’ work experience in a quality function in regulated environment, ie. medical devices or pharmaceutical industry
- Knowledge and experience of quality techniques: Six Sigma methods such as DFSS, DMAIC, DoE, FMEA, etc.
- cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC
- Knowledge of statistical methods

**What we offer**
- being encouraged to think and act entrepreneurially
- working in global teams and projects
- developing yourself professionally

Location: Singapore| Working hours: Full-time

Job ID: 53961 | Contact: Human Resources

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.