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Fulfill duties of the Quality Leads when they are unavailable
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Monitor incoming inspection release time on a regular basis
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Customer complaint handling and involvement in performing troubleshooting, investigations to determine root cause and provide solutions.
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Follow SOP and WI established in the quality management system to comply with ISO 13485:2016/MDSAP requirements in the designated function.
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Create training files for new employees and/or when required.
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Maintain training database.
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When required, perform investigation of returned goods
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Participate in internal and external audit activities
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Identify and report product defects, assist in investigations, root cause analysis, and implementing CAPAs.
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Escalate any new, unknown risk or hazards for further evaluation and decisions
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Work with multidisciplinary and cross-functional teams to ensure the timely completion and closure of deviations, investigations, product release for inbound and outbound.
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Calibrate and maintain testing and measurement equipment
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Participate in the Quality Review Board report completion and presentation
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Collaborate with other teams to address quality issues and support continuous improvement
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Following 5S at workplace.
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Assist in any other duties as required by the Quality Manager or Supervisor.
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Minimum 3 years experience in quality assurance role
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A degree in a relevant field; Engineering or Science field is preferred
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Educational background in Quality Assurance
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Knowledge of ISO 13485 and MDSAP requirements
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Technical skills include familiarity with Microsoft Office, Excel and SAP
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Experience in inspection techniques
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Experience in creating test plans and test strategies
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Demonstrate Leadership abilities
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Must be able to manage priorities and meet deadlines
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Ability to work independently as well as part of a team
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Important soft skills are attention to detail, analytical and problem solving abilities, communication skills and the ability to work independently and collaboratively