Executive, QA

**Qualification**
- Degree/Master in Chemist or equivalent
- IQA Auditor in ISO13485 and/or ISO 9001 or equivalent

**Skills**
- Analytical and logical.
- Able to communicate fluently in English and B. Malaysia.
- Good in report writing and record keeping.
- Well verse in ISO 9001 and/ or ISO 13485 requirements.
- Quality inspection, auditing and testing experience.

**Experience**
- Working experiences in manufacturing environment specializing in Quality Control/Assurance.
- Knowledge in handling the QA system in line of the company's policies and objectives independently.
- Assist to ensure customer complaints and customer enquiries related to QA/ RA are promptly attended to and resolved timely. Handling customer complaint and follow up with respective department to resolve the issues in an efficient and timely manner.
- To improve the QA activities and Quality Management System according to ISO 9001 & ISO 13485 Standard and applicable statutory and regulatory requirement.
- To implement or amend regulatory documentations to ensure regulatory compliance is maintained and enhanced.
- Providing advice on any new legislations, policies or procedure that may be introduced by the authority from time to time.
- To investigate complaints including reviewing and assessing investigation result and documents.
- To follow up on the CAPA implementation with agreed timescales.
- Assist for all product-related registration/approval e.g., Pre-market registration, post-market registration, new requirement registration etc.
- Assist to prepare and/ or verify documents that requested by customers, e.g., Pre-shipment report, product testing reports, product specification, MSDS and product/service agreements.
- Involvement in risk management activities including identify new risks, estimate probability of risk and impact, classify risk, recommend mitigation action/ risk control measures, assist in prioritizing risks, review and evaluate the medical benefit of the individual and overall residual risk.
- Assist in liaise with the users, customers and distributors/ authorized representatives regarding the necessary information required by the National Competent Authority arising from any incidents or near incidents in Vigilance System.
- Support Post Market Surveillance activities including customer satisfaction, customer complaint and feedback.
- To coordinate the submission of samples for customer evaluation. Keeping up to date with the changes in gloves industry regulatory news, updates, legislation guidelines and etc.
- Assist in Quality Management System (QMS) improvement programs to ensure compliance to applicable legal requirements.
- Assist General Manager (QA) by all means in:
Ø Provide regulatory guidance to General Manager (QA) to ensure manufacturing process and products distributions comply with the appropriate legislation.

Ø Coordinate with General Manager (QA) on any additional requirements regarding technical file and all related regulatory documentations.

Ø Studying and compiles information on data required pertaining to regulatory and project.

Ø Assist in liaise with customers, distributors, authorized representatives and regulatory authorities regarding the necessary information required by authorities.

Ø Other duties as assigned by General Manager (QA) from time to time.

**Salary**: RM2,300.00 - RM4,500.00 per month

**Benefits**:

- Dental insurance
- Free parking
- Health insurance
- Maternity leave
- Opportunities for promotion
- Parental leave

Schedule:

- Monday to Friday

Supplemental pay types:

- Performance bonus

Expected Start Date: 03/01/2024