Engineering Assistant, Quality

2 weeks ago


Singapore LEICA INSTRUMENTS (SINGAPORE) PTE LIMITED Full time

**Overview**:
You will be responsible for the daily review and analysis of customer complaints and to ensure that complaint information is available and adequate. You are expected to escalate any complaints that are potentially reportable and assist in complaint data input and analysis.

**Responsibilities**:
Complaint Handling:

- Ensure documentation is adequate
- Evaluation and obtaining information of Complaints
- Input of data into complaint handling system
- Perform tasks in a timely manner to ensure no outstanding complaints

Complaint Handling Database:

- Report, escalate and follow up when
- Complaint Handling system issues occur
- Ensure potential complaints outside complaint handling system are captured
- Maintenance and input of data into complaint handling system

Authority Reporting (MDR/MDV)
- Assist to report adverse events
- Early escalation of potential late reports
- Ensure documentation is adequate
- Comply and adhere to company Quality Management System and Environment, Health & Safety requirements.

**Requirements**:

- Diploma or equivalent qualification in Engineering related discipline.
- Familiar with medical device quality and complaint handling process is highly preferred.

**Personal Trait Profile**:

- Strong quality focus and understanding how good complaint handling helps to improve quality
- Hands on mentality in combination with solution-oriented mind-set
- Team player with ability to work alone
- Strong problem-solving skills
- Well organized, able to prioritize, ability to see the bigger picture
- High levels of integrity



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