Total 14 Quality Assurance job vacancies in Selangor

SRI is searching for highly organized and motivated individuals to join our award-winning International Sales team in a support role. 

Our export team is fast growing and will enable the chosen candidate to hone their interpersonal and organizational skills, as well as the opportunity to work with Malaysia's largest exporter of firefighting equipment.

 

Job Responsibilities:

• Monitoring daily production processes & output to ensure product compliances
• Perform in-process inspection & product outgoing inspection when necessary
• Process & product observation to detect unqualified matters
• Perform internal audits.
• Perform audit preparation and dealing with external auditors (from both local & OVERSEA)
• Product drawing review and technical support when necessary.
• Assist on issuing Certificate of Conformity and Test Report when necessary.
• Assist Head of QA on several administration job/task.
• Assist on new product project/development.
• Assist on dealing with notified/certification bodies when necessary (any assigned task)
• Assist on product testing (it would be COUNTLESS of trial and error), person with GOOD MENTALITY IS AN ADVANTAGE

 

Qualification / Minimum Requirements

 

• Manufacturing, Material, Process, Mechanical or other relevant engineering qualification EXCEPT Infrastructure & Architecture.
• Fresh Graduated or 2 years experience in factory or industrial environment
• QC and QA relevant experience are preferable
• Have some experience on handling new project (products & processes)
• Able to read & sketch mechanical drawing.
• Willing to work under minimal supervision to completed assigned task
• Good mentality is an advantage due to countless of product testing when necessary
• Willing to work longer hour when necessary

 

Employer questions

 

Your application will include the following questions:

• How many years' experience do you have as a Quality Assurance Engineer?
• Have you worked in a role which requires a sound understanding of ISO 9001?
• Which of the following languages are you fluent in?

 

Perks & Benefits

• Company trips
• Medical insurance

Responsibility:

1)      Project Development

• Development of equipment, jig and tool drawings.
• Testing to check the suitability of the products together with Production Engineer.
• Preparation of customer’s documentation.
• Etc.

 

2)      Production Process

• Setup new production method and process.
• Monitor and improve the current production method and process.
• Monitor in-process product in production area to ensure quality products are delivered to the customers.
• Record and analyze the production rejection rate on all items.
• Etc.

 

3)      Quality Issue and Improvement

• To investigate customer complaints and non-conformance issues arise (internal
• To develop, recommend and monitor corrective and preventive actions
• Preparation of document which is required by customer.
• Preparation of quality control plan, PFMEA and etc.
• Keep records of quality reports, statistical reviews and relevant documentation.
• Promote quality awareness and commitment to quality across the company and ensure all employees follow the quality requirements.
• Etc.

 

4)      Incoming & Outgoing Quality Documents

• Managing the incoming quality documents, ie COA, COC, Incoming Raw Material & Goods Check Sheet, etc.
• Preparation of Outgoing Quality Check Sheet.
• Etc.

 

5)      Calibration of Equipment, Jigs & Tools

• Monitor the schedule of calibration.
• Ensure the relevant parties are using the calibrated equipment, jig & tool and keep it properly.
• Etc.

 

6)      ISO Documentation and Audit Process

• Review and update relevant quality system procedures and work instructions.
• To coordinate and support on-site internal and external audits.
• To evaluate audit findings and implement appropriate corrective actions.

 

7)      Chemical Substances Management

• Consolidate the relevant information and documents, ie. ROHS report, ICP report, SOC report of the materials.
• Submission of relevant report to the customer.
• In charge of chemical handling & abnormalities.
• Ensure chemical management awareness on the shop floor.

 

8)      Any other tasks assigned by the Management from time to time.

 

Authority:

1. Release of new inspection jig.
2. Release of the calibrated measuring equipment.
3. Release of finished goods.
4. Suspend and stop the production process due to nonconformity and abnormality found.
5. Decide the action on the rejected parts that have a rejection rate is less than 3%.
6. Acknowledgement of Incoming Raw Material & Goods Check Sheet.

Perks & Benefits

• Commission and bonus
• Allowance (travel stipends, transportation, etc.)
• Casual dress code
• Medical insurance
• Personal leave

Responsibilities

• Responsible for ensuring the software products developed meet the highest quality standards and to lead a team of testers and work closely with Product Specialist, Business Analyst, Developers, and other stakeholders to coordinate testing activities, develop and implement test plans, execute tests, identify, and document defects, and manage the testing team.
• Develop and implement comprehensive test plans and test cases that meet project requirements and business needs.
• Collaborate with project managers, developers, and other stakeholders to understand project objectives, timelines, and requirements.
• Provide 1:1 coaching to team members if necessary.
• To assist the Heads of Departments in overseeing team members, ensuring departmental alignment with the organization's strategic goals, and prepare comprehensive reports when necessary.
• Adherence to all relevant laws, regulations, and compliance requirements, as well as managing the implementation of and adherence to the organization's/department information security policy and management system in all aspects of operations
• To assist in managing and preparing the department's intellectual property and assets, which encompass methodologies, best practices, technical know-how, knowledge base, processes, and procedural frameworks, and to perform any other tasks as assigned by the middle management.
• Prepare and maintain Test Traceability Matrix that can be used by stakeholders to identify relationships between requirements, test cases and test results as a reference point to track testing activities and ensure comprehensive coverage.
• Stay abreast of latest test automation, automation tools and frameworks also with new trends, open source, continuous integration, and continuous development.
• Quantify, manage, track and report test related statuses, SLA and KPIs, and ensure that defined testing transformation SLA and KPI targets are met for the portfolio accountable.
• Establish and maintain test schedules, including planning, execution, and reporting.
• Monitor and track defects and ensure that they are resolved in a timely and efficient manner.
• Communicate testing progress and issues to project managers and other stakeholders, including identifying and reporting risks and providing recommendations for mitigation.
• Participate in project planning and status meetings, providing testing expertise and insights as needed.
• Utilize testing tools and technologies to streamline testing processes and improve test coverage, including test automation, performance testing, and security testing.
• Continuously evaluate and improve the testing process, including implementing best practices and identifying opportunities for process optimization and efficiency.

Requirements & Qualification

• Bachelor’s degree in computer science or any related field.
• Minimum 8 years work experience in a similar role is required for this position:
• Have IT knowledge of QA strategy, process, tools and be able to drive and execute software QA projects.
• High attention to detail and solid analytical skills.
• Excellent documentation skills.
• Fundamental analytical and conceptual thinking skills.
• Experience creating detailed reports and giving presentations.
• Competency in Microsoft applications including Word, Excel, and Outlook.
• Strong knowledge of testing methodologies, test case design, and execution.
• Well-organized, independent, detailed, and able to meet committed deadlines.
• Experience in writing automation test scripts and test execution.
• Working knowledge of test automation software (e.g., Selenium, qTest, Katalon, Appium)
• Experience in JMeter is an added advantage.
• ISTQB certification is an added advantage.

• Nearby public transport
• Casual dress code
• Free-flow pantry
• Regular sports & team activities
• Medical insurance
• Career development opportunities
• Flexi benefit for work-life balance

職責

• 負責確保開發的軟體產品符合最高品質標準，並領導測試人員團隊，並與產品專家、業務分析師、開發人員和其他利害關係人密切合作，協調測試活動、制定和實施測試計劃、執行測試、識別、記錄缺陷並管理測試團隊。
• 制定並實施滿足專案要求和業務需求的全面測試計劃和測試案例。
• 與專案經理、開發人員和其他利害關係人合作，了解專案目標、時間表和要求。
• 如有必要，為團隊成員提供一對一輔導。
• 協助部門主管監督團隊成員，確保部門與組織的策略目標一致，並在必要時準備綜合報告。
• 遵守所有相關法律、法規和合規要求，並管理組織/部門資訊安全政策和管理系統在營運各個方面的實施和遵守
• 協助管理和準備部門的智慧財產權和資產，其中包括方法、最佳實踐、技術知識、知識庫、流程和程序框架，並執行中階管理人員分配的任何其他任務。
• 準備和維護測試可追溯性矩陣，利害關係人可以使用該矩陣來識別需求、測試案例和測試結果之間的關係，作為追蹤測試活動並確保全面覆蓋的參考點。
• 隨時了解最新的測試自動化、自動化工具和框架以及新趨勢、開源、持續整合和持續開發。
• 量化、管理、追蹤和報告測試相關狀態、SLA 和 KPI，並確保負責的產品組合滿足定義的測試轉換 SLA 和 KPI 目標。
• 建立和維護測試計劃，包括計劃、執行和報告。
• 監控和追蹤缺陷並確保及時有效地解決它們。
• 向專案經理和其他利害關係人傳達測試進度和問題，包括識別和報告風險以及提供緩解建議。
• 參加專案規劃和狀態會議，根據需要提供測試專業知識和見解。
• 利用測試工具和技術來簡化測試流程並提高測試覆蓋率，包括測試自動化、效能測試和安全測試。
• 持續評估和改進測試流程，包括實施最佳實踐並識別流程優化和效率的機會。

要求和資格

• 計算機科學或任何相關領域的學士學位。
• 該職位需要至少 8 年類似職位的工作經驗：
• 擁有 QA 策略、流程、工具的 IT 知識，並且能夠推動和執行軟體 QA 專案。
• 高度關注細節和紮實的分析能力。
• 出色的文檔編寫能力。
• 基本的分析和概念思考能力。
• 擁有建立詳細報告和進行簡報的經驗。
• 具備 Microsoft 應用程式（包括 Word、Excel 和 Outlook）的能力。
• 對測試方法、測試案例設計和執行有豐富的了解。
• 組織良好、獨立、詳細且能夠在承諾的期限內完成。
• 具有編寫自動化測試腳本和測試執行的經驗。
• 測試自動化軟體的使用知識（例如，Selenium、qTest、Katalon、Appium）
• 使用 JMeter 的經驗是一個額外的優勢。
• ISTQB 認證是一個額外的優勢。

• 附近的公共交通
• 休閒著裝要求
• 自由流通的食品儲藏室
• 定期體育和團隊活動
• 醫療保險
• 職涯發展機會
• 平衡工作與生活的彈性福利

JOB SCOPE :

 

-        Monitoring operations to ensure that they meet production standards.

-        Recommending adjustments to the assembly or production process. Inspecting, testing, or measuring materials or products being produced. 

-        Responsible for QC department document filling system.

-        To compile of daily QC record and compute into QC daily report.

-        To undertake any other related job such as typing, report, Preparation, etc

REQUIREMENT :

 

-        Must possess minimum Secondary School / SPM / “O” level / Diploma or equivalent.

-        At least 1 year experience required.

-        PC literate and proficient in Microsoft Office with good typing skills.

-        Knowledge of the requirement of ISO 9001:2015 is essential. 

 

 

 

 

-        Responsible for completing finished product quality checks for assembly lines, tracking of non-conforming materials and products and documentation of daily paperwork

-        Responsible for reviewing products and materials during Operation to make sure they meet client requirements.

-        Perform sampling quality inspection on the prepared stock based on the client specification / requirement before release for storage / delivery.

-        Reject all products and materials that fail to meet quality expectations.

-        Read Work Instruction and product specifications to understand the requirements of the products and services.

-        Recommend improvements to the production process to ensure quality control.

-        Document inspection outcomes by completing detailed reports and performance records.

-        Teach or guide the production team about quality control concerns to improve product excellence.

-        Resolve quality-related issues in a timely manner.

-        Assist in internal audits and external audits (SGS audit, client / customer audit, regulatory audit)

-        Other tasks as and when required by the HOD

-        Perform regular quality assessments on all incoming materials from vendors

5 working days (Regular Hour)

Dental Subsidy

工作範圍 ：

- 監控操作以確保其符合生產標準。

- 建議調整組裝或生產流程。檢查、測試或測量正在生產的材料或產品。

- 負責QC部門文件填寫系統。

- 編制每日QC記錄並計算成QC日報。

- 承擔任何其他相關工作，如打字、報告、準備等

要求 ：

- 必須至少擁有中學/SPM/“O”水準/文憑或同等學歷。

- 需至少 1 年經驗。

- 懂電腦，精通 Microsoft Office，並具備良好的打字能力。

- 了解 ISO 9001:2015 的要求至關重要。

- 負責完成裝配線的成品品質檢查、不合格材料和產品的追蹤以及日常文書工作的記錄

- 負責在營運期間審查產品和材料，以確保其滿足客戶要求。

- 在放行儲存/交貨之前，根據客戶的規格/要求對準備好的庫存進行抽樣品質檢驗。

- 拒絕所有不符合品質期望的產品和材料。

- 閱讀工作指導和產品規格，以了解產品和服務的要求。

- 建議改善生產流程以確保品質控制。

- 透過完成詳細的報告和績效記錄來記錄檢查結果。

- 教導或指導生產團隊有關品質控制問題，以提高產品卓越性。

- 及時解決品質相關問題。

- 協助內部審核和外部審核（SGS審核、客戶/客戶審核、監管審核）

- HOD要求時的其他任務

- 對供應商的所有進料進行定期品質評估

5個工作天（正常時間）

牙科補貼

Unique Fire Holdings Berhad focuses on the assembly, manufacture and distribution of active fire protection systems, equipment, and accessories. Our comprehensive range of products continue to reliably serve customers in Malaysia and abroad. Our export markets include ASEAN countries and the Middle East.

After our public-listing exercise, we are currently undergoing major expansion and we invite all enthusiasts and energetic individuals to join our growing team.

 

Job Description:

• Oversee the quality control activities including inspection/testing records on incoming goods (IQC), process inspection (PQC), final inspection (FQC), and product performance test.
• Raise defective product complaint reports to suppliers, especially on receiving product defects, in- process inspection, and product improvement.
• Conduct inspection on nonconformance products “Discrepant Material Report” (DMR) and register into the Epicor system on manufacturing products.
• Investigate defective products in production and customer complaints (RMA) and follow up with corrective actions taken to ensure effectiveness.
• Identify the cause of product failure and recommend a “Corrective Action Request” (CAR).
• Monitor and verify data collection on the “Overall Equipment Effectiveness” system (OEE) in Manufacturing/Production.
• Monitoring validation/calibration equipment (internal and external calibration provider).
• Assist internal and external audits such as SIRIM, ISO Management System, etc.
• Ensure all controlled documents and quality records are maintained according to procedures.
• Perform report, product inspection/testing samples from the vendor/research & development purpose
   

Job Requirements:

• At least 2 years of working experience in safety preferably from the manufacturing industry
• Sound knowledge of Occupational Safety and Health Regulations (OSH)
• Proactive and resourceful
• Able to communicate effectively in English and Bahasa Malaysia

 

The perks:

• Career & development opportunities - networking events, conferences, training, and certification sponsored by the company.
• Overtime and travel allowance.
• Company engagement activities (annual dinner, team building, festive celebration etc)
• Medical, optical and dental benefits (in-panel clinic)
• Rewards and recognitions

Benefit:

• 5 Working Days
• Birthday Leave
• OT & Attendance Allowance 

Bjak is focused on providing access to affordable and sustainable financial services for people in ASEAN. Headquartered in Malaysia, Bjak is the largest insurance portal in Southeast Asia. Our main portal, Bjak.com, helps millions find the insurance policy with the best value and highest coverage for them. Our investments in technology such as Custom API, blockchain, trading systems and data science is to enable easy access to financial services that were previously inaccessible or difficult to understand.

Our core strengths are in navigating the most complex regulations and environments, creating some of the most innovative products in the world. For instance, we are the first platform globally to simplify and offer investment-linked life and health insurance online, coupled with an instant talk-to-agent service.

Job Summary: We're seeking a sharp Quality Assurance Specialist with expertise in life insurance. You'll be responsible for maintaining high-quality standards, ensuring regulatory compliance, and driving efficiency improvements. Collaboration with teams to pinpoint enhancement opportunities, including monitoring the quality of calls and chats by telesales, customer experience, and sales staff, is key.

Key Responsibilities

• Evaluate Calls and Chats: Assess the quality of telesales, customer experience, and sales staff interactions, providing feedback and coaching for improvement.
• Develop and Implement Quality Assurance Processes: Create and enforce rigorous quality assurance protocols tailored to our life insurance operations.
• Data Analysis for Improvement: Analyze data to identify areas for enhancement and provide actionable insights for improvement.
• Provide Training on Quality Standards: Deliver training programs to ensure staff understanding and compliance with quality standards.
• Lead Continuous Improvement Initiatives: Drive initiatives to enhance operational efficiency and quality across all processes.

• Bachelor's degree in relevant field.
• years of experience in life insurance QA or similar role.
• Strong understanding of life insurance products and regulations.
• Analytical mindset with high attention to detail.
• Excellent communication skills.

• Fast moving, challenging and unique business problems

• Strong learning and development plans for your career growth
• International work environment and flat organization
• Competitive salary
• Flexible working arrangement
• Casual work attire

Bjak is focused on providing access to affordable and sustainable financial services for people in ASEAN. Headquartered in Malaysia, Bjak is the largest insurance portal in Southeast Asia. Our main portal, Bjak.com, helps millions find the insurance policy with the best value and highest coverage for them. Our investments in technology such as Custom API, blockchain, trading systems and data science is to enable easy access to financial services that were previously inaccessible or difficult to understand.

Our core strengths are in navigating the most complex regulations and environments, creating some of the most innovative products in the world. For instance, we are the first platform globally to simplify and offer investment-linked life and health insurance online, coupled with an instant talk-to-agent service.

Job Summary: We're seeking a sharp Quality Assurance Manager with expertise in life insurance. You'll be responsible for maintaining high-quality standards, ensuring regulatory compliance, and driving efficiency improvements. Collaboration with teams to pinpoint enhancement opportunities, including monitoring the quality of calls and chats by telesales, customer experience, and sales staff, is key.

Key Responsibilities

• Evaluate Calls and Chats: Assess the quality of telesales, customer experience, and sales staff interactions, providing feedback and coaching for improvement.
• Develop and Implement Quality Assurance Processes: Create and enforce rigorous quality assurance protocols tailored to our life insurance operations.
• Data Analysis for Improvement: Analyze data to identify areas for enhancement and provide actionable insights for improvement.
• Provide Training on Quality Standards: Deliver training programs to ensure staff understanding and compliance with quality standards.
• Lead Continuous Improvement Initiatives: Drive initiatives to enhance operational efficiency and quality across all processes.

• Bachelor's degree in relevant field.
• years of experience in life insurance QA or similar role.
• Strong understanding of life insurance products and regulations.
• Analytical mindset with high attention to detail.
• Excellent communication skills.

• Fast moving, challenging and unique business problems

• Strong learning and development plans for your career growth
• International work environment and flat organization
• Competitive salary
• Flexible working arrangement
• Casual work attire

Bjak is focused on providing access to affordable and sustainable financial services for people in ASEAN. Headquartered in Malaysia, Bjak is the largest insurance portal in Southeast Asia. Our main portal, Bjak.com, helps millions find the insurance policy with the best value and highest coverage for them. Our investments in technology such as Custom API, blockchain, trading systems and data science is to enable easy access to financial services that were previously inaccessible or difficult to understand.

Our core strengths are in navigating the most complex regulations and environments, creating some of the most innovative products in the world. For instance, we are the first platform globally to simplify and offer investment-linked life and health insurance online, coupled with an instant talk-to-agent service.

Job Summary: We're seeking a sharp QA Supervisor with expertise in life insurance. You'll be responsible for maintaining high-quality standards, ensuring regulatory compliance, and driving efficiency improvements. Collaboration with teams to pinpoint enhancement opportunities, including monitoring the quality of calls and chats by telesales, customer experience, and sales staff, is key.

Key Responsibilities

• Evaluate Calls and Chats: Assess the quality of telesales, customer experience, and sales staff interactions, providing feedback and coaching for improvement.
• Develop and Implement Quality Assurance Processes: Create and enforce rigorous quality assurance protocols tailored to our life insurance operations.
• Data Analysis for Improvement: Analyze data to identify areas for enhancement and provide actionable insights for improvement.
• Provide Training on Quality Standards: Deliver training programs to ensure staff understanding and compliance with quality standards.
• Lead Continuous Improvement Initiatives: Drive initiatives to enhance operational efficiency and quality across all processes.

• Bachelor's degree in relevant field.
• years of experience in life insurance QA or similar role.
• Strong understanding of life insurance products and regulations.
• Analytical mindset with high attention to detail.
• Excellent communication skills.

• Fast moving, challenging and unique business problems

• Strong learning and development plans for your career growth
• International work environment and flat organization
• Competitive salary
• Flexible working arrangement
• Casual work attire

Bjak is focused on providing access to affordable and sustainable financial services for people in ASEAN. Headquartered in Malaysia, Bjak is the largest insurance portal in Southeast Asia. Our main portal, Bjak.com, helps millions find the insurance policy with the best value and highest coverage for them. Our investments in technology such as Custom API, blockchain, trading systems and data science is to enable easy access to financial services that were previously inaccessible or difficult to understand.

Our core strengths are in navigating the most complex regulations and environments, creating some of the most innovative products in the world. For instance, we are the first platform globally to simplify and offer investment-linked life and health insurance online, coupled with an instant talk-to-agent service.

Job Summary: We're seeking a sharp Senior Quality Assurance with expertise in life insurance. You'll be responsible for maintaining high-quality standards, ensuring regulatory compliance, and driving efficiency improvements. Collaboration with teams to pinpoint enhancement opportunities, including monitoring the quality of calls and chats by telesales, customer experience, and sales staff, is key.

Key Responsibilities

• Evaluate Calls and Chats: Assess the quality of telesales, customer experience, and sales staff interactions, providing feedback and coaching for improvement.
• Develop and Implement Quality Assurance Processes: Create and enforce rigorous quality assurance protocols tailored to our life insurance operations.
• Data Analysis for Improvement: Analyze data to identify areas for enhancement and provide actionable insights for improvement.
• Provide Training on Quality Standards: Deliver training programs to ensure staff understanding and compliance with quality standards.
• Lead Continuous Improvement Initiatives: Drive initiatives to enhance operational efficiency and quality across all processes.

• Bachelor's degree in relevant field.
• years of experience in life insurance QA or similar role.
• Strong understanding of life insurance products and regulations.
• Analytical mindset with high attention to detail.
• Excellent communication skills.

• Fast moving, challenging and unique business problems

• Strong learning and development plans for your career growth
• International work environment and flat organization
• Competitive salary
• Flexible working arrangement
• Casual work attire

Bjak is focused on providing access to affordable and sustainable financial services for people in ASEAN. Headquartered in Malaysia, Bjak is the largest insurance portal in Southeast Asia. Our main portal, Bjak.com, helps millions find the insurance policy with the best value and highest coverage for them. Our investments in technology such as Custom API, blockchain, trading systems and data science is to enable easy access to financial services that were previously inaccessible or difficult to understand.

Our core strengths are in navigating the most complex regulations and environments, creating some of the most innovative products in the world. For instance, we are the first platform globally to simplify and offer investment-linked life and health insurance online, coupled with an instant talk-to-agent service.

Job Summary: We're seeking a sharp Quality Control Inspector with expertise in life insurance. You'll be responsible for maintaining high-quality standards, ensuring regulatory compliance, and driving efficiency improvements. Collaboration with teams to pinpoint enhancement opportunities, including monitoring the quality of calls and chats by telesales, customer experience, and sales staff, is key.

Key Responsibilities

• Evaluate Calls and Chats: Assess the quality of telesales, customer experience, and sales staff interactions, providing feedback and coaching for improvement.
• Develop and Implement Quality Assurance Processes: Create and enforce rigorous quality assurance protocols tailored to our life insurance operations.
• Data Analysis for Improvement: Analyze data to identify areas for enhancement and provide actionable insights for improvement.
• Provide Training on Quality Standards: Deliver training programs to ensure staff understanding and compliance with quality standards.
• Lead Continuous Improvement Initiatives: Drive initiatives to enhance operational efficiency and quality across all processes.

• Bachelor's degree in relevant field.
• years of experience in life insurance QA or similar role.
• Strong understanding of life insurance products and regulations.
• Analytical mindset with high attention to detail.
• Excellent communication skills.

• Fast moving, challenging and unique business problems

• Strong learning and development plans for your career growth
• International work environment and flat organization
• Competitive salary
• Flexible working arrangement
• Casual work attire

     

JOB DESCRIPTION:

PRIMARY OBJECTIVE:
Responsible for Quality Management system and to be 100% compliance with Corporate, Divisional and local regulations.

CORE JOB RESPONSIBILITIES:

• Support in developing, implementing, assuring and monitoring the Quality and Regulatory Compliance strategies of the company
• Supports Complaint Handling/ post market surveillance and follow up actions
• Assignment of QMS training to employees on quality related documents and policies
• Preparation of monthly KPI data
• Provide inputs for Management Review Meeting including updates on adequacy and effectiveness of Quality Management system.
• Manages the document control for QMS procedures and quality records
• Support and prepare affiliate for Internal & External Quality & Compliance Audits.
• Prepare and help to obtain and maintain the GDPMD Certification and/or applicable Quality related certification in the region.
• Support external, internal and supplier audit and the follow-up remediation plan.
• Support investigation, defining root-cause and implementation of Corrective Action and Preventive Actions in a timely manner.
• Execution of Product Stop Shipment, Field Safety Corrective Actions as per instructions from Regional or Divisional QA.
• Interacts on a periodic frequency with Commercial, Regulatory Affairs, Supply Chain, Technical Service, Education and other functions on all quality related matters.
• Manage the change control process to meet amendment to local regulatory compliance requirements.
  OTHER FUNCTIONS AND RESPONSIBILITIES:
• Perform various administrative functions as required.
• Any other activities as assigned time to time by Line Manage

EDUCATION/QUALIFICATIONS/EXPERIENCE:

• Minimum of Bachelor’s degree in Science. Equivalent education/work experience will be considered.
• Working experience in a Commercial Quality environment in Medical Device or Pharmaceutical organization will be of advantage.
• Knowledge of local Medical Device regulations
• Computer proficiency in Word, Excel and PowerPoint.
• Strong interpersonal skills, with the ability to build and maintain relationships.
• Effective time management - well organized, able to set and reset priorities
• Strong oral and written communication skills.
• Detail and deadline oriented.
• Conversant local language as well both written and spoken English.
• Ability to work and flourish in a fast-paced multi-tasked environment
• Demonstrates a highly positive attitude concerning risk, change and unexpected challenges.
• Tendency to be friendly, cooperative, agreeable. To be a team person. Promotes the benefits of teamwork and cooperation. Is usually willing to share resources and information.
• Good in English Communication Skills

EXPERIENCE REQUIRED:

• Working experience in a Commercial Quality environment in Medical Device or Pharmaceutical organization will be of advantage.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

AVD Vascular

        

LOCATION:

Malaysia > Selangor : Imazium, No. 8, Jalan SS 21/37

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     

     

     

1. Carry out the analysis of incoming samples properly and correctly by applicable procedures and provisions and report all inspection/analysis results.

2. Analyze the sample related to the selection of new suppliers

3. Provide status of analysis results and report to supervisor.

4. Inspecting the cleanliness and suitability of loading raw materials and products by Work Instructions and reporting to supervisor.

5. Maintain all documents related to the results of the analysis and examination.

6. Coordinate with PPIC and production in quality aspects.

7. Responsible for maintaining all work equipment and cleanliness at the Quality Department location.

8. Implement company regulations and K3 regulations that apply at PT. LDC Indonesia.

9. Maintain and strive for work discipline to be carried out with full awareness.