Quality Assurance Engineer

2 weeks ago

Singapore BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE. LTD. Full time

**Summary**
- Provide Quality Engineering support to R&D teams for new product development and product enhancement via Design Control process
- Provide support to Clinical team for pre-market device deficiencies and Complaint Handling Unit for post-market complaints investigation
- Coordinator of Risk Management process within the organization
- 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 the scheduling of engineering changes and operation flow as well as company-wide improvement programs and assigned quality projects. Support the global PMS program, and responsible for timely complaint investigation for on-time vigilance reporting and complaint cases closure.

**Responsibility**
- Identify quality requirements and support design control process and design history files.
- Provide QA related support for new product development and product enhancement.
- Generate or review validation/verification documents, provide support to Quality investigation related to Validation/Verification reject investigation.
- Generate or Update Quality related documents such as Quality Plan, Quality Inspection documents and Lot release Documents during the development phase.
- Coordinate the update of incoming material specs and FAI activities with the Supplier Management Group during the development phase.
- Lead and perform Product Risk Management for current, new/enhanced products.
- Maintain Risk Management Files and Risk Management Plans in accordance to EN ISO 14971
- Carry out DHR review, returned device decontamination and returned device investigation
- Responsible for returning of 3rd party complaint products to manufacturers Involve in internal audits, external audits and Quality Assurance related projects when required.

**Requirement**
- A Bachelor Degree in Engineering
- At least 3-5 years of medical device experience
- Ability to communicate 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
- Familiar with ISO 13485, ISO 14971, ISO 25539 and ISO 10555 requirements
- Knowledgeable of applicable cGMP’S, FDA, MDD (93/94/EEC) and MDR (2017/745)
- Knowledge of FMEA, Design Control, Statistical Process Control (SPC) and Problem Solving Tools is preferable
- Able to recommend critical decisions with calculated and justifiable risk through analytical thinking

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