QA/ Ra Executive

4 days ago


Semenyih, Malaysia MEDISAFE TECHNOLOGIES SDN BHD Full time

**Key Responsibilities (not limited to:)**
- Evaluating current and new products for compliance with applicable current regulations
- Ensure that a company's products comply with the regulations of the regions where they want to distribute them
- Stay abreast of new applicable laws and provide organizational management with updates on how the changes will affect the business.
- Responsible for preparation of all related documents for products registration with
- Conformity Assessment Body (CAB) and Medical Device Authority (MDA)
- Liaising with local/foreign manufacturer/supplier to compile all technical file for products registration i.e CSDT, DOC, Risk Analysis etc.
- Outlining requirements for labelling, storage, and packaging
- Keep up to date with national and international legislation, regulation, guidelines, and customer practices
- Liaising with external lab on the quotation on any testing required by customer and follow up with external lab the result.
- Receive and manage customer complaints. Complaints received will be reported to manufacturers for further investigation and will be reported to Medical Device Authority to comply with Malaysian regulation.
- Investigation results will be shared to customer through Business Development team.
- Collect, collate, and evaluate scientific data from a range of sources
- Write clear, accessible product labels and patient information leaflets.
- Control registration of company/ product certification and monitoring expired date.
- Ensuring that quality standards are met, and submissions meet strict deadlines.
- Perform an ad-hoc task that assigns by superior from time to time

**Quality Assurance**
- Responsible for GDPMD & ISO 13485 implementation in the company
- Determined, plan and conduct audit include internal and external audit and prepare the audit report
- Plan for various department and ensure that reviews are carried out in accordance with the audit plan and completed time
- Updating all report on Non-Conformance and ensure all department compliance
- Control and update all iso relevant document and ensure all department documentation is up to date
- Assist management in the implementation of ISO 13485 and GDPMD and develop and enhance new and current operating
- To liaise with consultant to prepare and update QMS documentation
- Continuously improve knowledge regarding sector’s rules, relation and technique and performance standard.
- Coordinate customer complaint and CAPA
- Train personnel in compliance of ISO 13485 and GDPMD
- Perform an ad-hoc task that assigns by superior from time to time
- **Education**:Degree in a related field, such as biomedical science, engineering, or a related discipline.
- **Experience**:Several years of experience in quality assurance, quality control, or regulatory affairs within the medical device industry.
- **Knowledge**:Strong understanding of medical device regulations (e.g., ISO 13485, FDA QSR, MDR), quality management systems, and validation processes.
- **Skills**:Excellent communication, problem-solving, and analytical skills.

**Job Types**: Full-time, Permanent, Fresh graduate

Pay: RM3,000.00 - RM3,500.00 per month

**Benefits**:

- Maternity leave
- Opportunities for promotion
- Professional development

Work Location: In person

Application Deadline: 02/12/2024
Expected Start Date: 09/15/2025


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