Total 6 job vacancies by Elastomade Accessories Sdn Bhd

Functions:

1. To manage the regulatory compliance function of the company, which include medical device registration, post market surveillance, clinical evaluation.
2. To ensure compliance with regulatory requirements from countries / regions such as the EU (MDR), US (FDA), Malaysia (MDA) and so on.
3. To develop and maintain Technical Documentation for each medical device category.
4. To participate in developing and maintaining Standard Operating Procedures, Work Instructions and Specifications that comply with the relevant regulatory and customer requirements.
5. To keep abreast of the regulatory changes and its implications, keeping management apprised at all times.

Profile:

1. Degree / diploma in medical, engineering, science or regulatory field
2. A minimum of 2 years' experience in regulatory affairs in the medical device industry
3. Practical experience in dealing with regulatory bodies (Malaysia MDA or foreign authorized representative such as the EU)
4. Good organization skills and proactive in ensuring regulatory requirement are met.
5. Good communication skills to maintain communication with external and internal stakeholders.
6. Good written skills in English.
7. Auditing experience in ISO 13485 or GDPMD will be and added advantage.

Perks & Benefits

• Medical insurance
• Personal leave

Job Description

Quality Control is responsible for making sure that products meet a set of standards. Their duties include examining incoming raw material, measuring the specifications of random items in each production run test the physical properties of rubber product with use of laboratory test equipment.

Duties/Responsibilities:

1. Inspecting output samples using industry-appropriate methods, such as comparing to standards, measuring dimensions and examining functionality.
2. Recording inspection results by completing reports, summarizing re-works and waste and inputting data into quality database.
3. Work closely with production team on quality control measures to improve product excellence.
4. To check and examine the incoming raw material as per ISO requirement.
5. To do test on physical properties of rubber product to every lot of order with use of laboratory equipment and record.
6. Keeping measurement equipment operating accurately by following calibration requirements and calling for repairs.
7. Determining the causes of product defects and reworks.
8. Verifying all equipment is calibrated correctly.

Quality Control Skills and Qualifications:

1. Good written and verbal communications skills
2. Keen attention to detail
3. Basic computer and math skills to calibrate and measure specifications
4. Ability to use measuring devices like ruler, callipers and test equipment.
5. Documentation and reporting skills
6. Teamwork and collaboration
7. Education level - Minimum SPM

Perks & Benefits

• Medical insurance
• Personal leave

Functions:

1. To manage the regulatory compliance function of the company, which include medical device registration, post market surveillance, clinical evaluation.
2. To ensure compliance with regulatory requirements from countries / regions such as the EU (MDR), US (FDA), Malaysia (MDA) and so on.
3. To develop and maintain Technical Documentation for each medical device category.
4. To participate in developing and maintaining Standard Operating Procedures, Work Instructions and Specifications that comply with the relevant regulatory and customer requirements.
5. To keep abreast of the regulatory changes and its implications, keeping management apprised at all times.

Profile:

1. Degree / diploma in medical, engineering, science or regulatory field
2. A minimum of 2 years' experience in regulatory affairs in the medical device industry
3. Practical experience in dealing with regulatory bodies (Malaysia MDA or foreign authorized representative such as the EU)
4. Good organization skills and proactive in ensuring regulatory requirement are met.
5. Good communication skills to maintain communication with external and internal stakeholders.
6. Good written skills in English.
7. Auditing experience in ISO 13485 or GDPMD will be and added advantage.

Perks & Benefits

• Medical insurance
• Personal leave

職位描述

品質控制負責確保產品符合一組標準。他們的職責包括檢查傳入的原材料、測量每次生產運行中隨機項目的規格、使用實驗室測試設備測試橡膠產品的物理性能。

職責/責任：

1. 使用適合行業的方法檢查輸出樣品，例如與標準進行比較、測量尺寸和檢查功能。
2. 透過完成報告、總結返工和浪費並將數據輸入品質資料庫來記錄檢驗結果。
3. 與生產團隊在品質控制措施上密切合作，以提高產品的卓越性。
4. 根據 ISO 要求檢查和檢驗傳入的原料。
5. 利用實驗室設備對每批訂單的橡膠製品物理性能進行測試並記錄。
6. 透過遵循校準要求並要求維修來保持測量設備準確運作。
7. 確定產品缺陷和返工的原因。
8. 驗證所有設備均已正確校準。

品質控制技能和資格：

1. 良好的書面和口頭溝通能力
2. 注重細節
3. 用於校準和測量規格的基本計算機和數學技能
4. 能夠使用尺、卡尺和測試設備等測量設備。
5. 文件和報告技能
6. 團隊合作
7. 教育程度 - 最低 SPM

津貼和福利

• 醫療保險
• 事假

醫學、工程、科學或監管領域的學位/文憑

至少 2 年醫療器材產業監管事務經驗

與監管機構打交道的實際經驗（馬來西亞MDA或歐盟等外國授權代表）

良好的組織能力並積極主動地確保滿足監管要求。

良好的溝通能力，與外部和內部利害關係人保持溝通。

良好的英語寫作能力。

ISO 13485 或 GDPMD 的審核經驗將是額外的優勢。

津貼和福利

• 醫療保險
• 事假

Functions:

1. To manage the regulatory compliance function of the company, which include medical device registration, post market surveillance, clinical evaluation.
2. To ensure compliance with regulatory requirements from countries / regions such as the EU (MDR), US (FDA), Malaysia (MDA) and so on.
3. To develop and maintain Technical Documentation for each medical device category.
4. To participate in developing and maintaining Standard Operating Procedures, Work Instructions and Specifications that comply with the relevant regulatory and customer requirements.
5. To keep abreast of the regulatory changes and its implications, keeping management apprised at all times.

Profile:

1. Degree / diploma in medical, engineering, science or regulatory field
2. A minimum of 2 years' experience in regulatory affairs in the medical device industry
3. Practical experience in dealing with regulatory bodies (Malaysia MDA or foreign authorized representative such as the EU)
4. Good organization skills and proactive in ensuring regulatory requirement are met.
5. Good communication skills to maintain communication with external and internal stakeholders.
6. Good written skills in English.
7. Auditing experience in ISO 13485 or GDPMD will be and added advantage.

Perks & Benefits

• Medical insurance
• Personal leave