Quality Engineer

7 days ago

Singapore BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE. LTD. Full time

**Position Summary**
- Support the global Post Market Surveillance (PMS) program, and responsible for timely complaint investigation and complaint cases closure for on-time vigilance reporting
- Provide support to Clinical team for pre-market product related device deficiencies and Complaint Handling Unit (CHU) for post-market complaints investigation (including PMCFs and registries etc.) / analysis of complaint trend data
- Responsible for carrying out quality programs that contribute to improve both product and process quality and reliability, and to minimize risk exposure through control systems, procedures, methods and practices designed to carry out these objectives consistently.
- Participate in company-wide improvement programs and assigned quality projects.

**Position Responsibilities**
- Carry out DHR review and impact assessment for complaint/device deficiency
- Reponsible for arranging returned device for decontamination and processing of angiography record for review
- Perform returned device investigation - inclusive of engineering analysis or tests to establish event rootcause and determination of final device problem
- Assignment of IMDRF code for each case
- Ensure proper assessment of risk and feedback into Risk Management Files in accordance to ISO 14971
- Support Risk Management Program to perform periodic review of Risk Management Files
- Responsible for following up with correction/corrective actions when device-related deficiencies are found
- On-time completion of Product Investigation reports
- Provide interim communication to customer on status of complaint product (e.g. receipt of returned complaint product, completion of DHR review/ impact assessment)
- Maintainence of complaint investigation room - inclusive of investigation equipment and arrangement for the disposal of biohazardous waste
- Streamline and improve efficiency of complaint product investigation
- Support Complaint Handling Unit (CHU) for generation of complaint trending data and evaluation of risks associated with the use of related devices to determine if FSCA or issuance of trend report is required
- Responsible for returning of 3rd party complaint products to manufacturers
- Involve in internal audits, external audits and Quality Assurance related projects when required

**Experiences, Knowledge, Skills and Abilities**
- A Bachelor Degree in Engineering
- At least 1-2 years of medical device experience
- Good oral and written communication skills in English
- Experience in Problem Solving
- Cleanroom/environmental control experience is preferable
- Excellent interpersonal and communication skill and possess positive attributes
- High level of integrity and able to work under stress and deliver work as per scheduled
- Good communication and interpersonal skills to build cross function and support
- Self-starter and independent
- Understanding of medical terminology and familiarity with principles of clinical assessment of adverse events in the medical device industry is highly desirable.
- Familiar with ISO 13485 and ISO 14971 requirements
- Knowledgeable of applicable cGMP’S, FDA, MDD (93/94/EEC) and MDR (2017/745)
- Knowledge of FMEA and Root Cause Analysis / Problem Solving Tools is preferable
- Able to recommend critical decisions with calculated and justifiable risk through analytical thinking

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