Total 41 qa manager job vacancies in Quality Assurance / Control category in Johor Bahru or Petaling Jaya

Job Responsibilities:

1. New product registration:

• Prepare and compile registration dossiers in accordance with relevant regulatory requirements including: 
  

  • Constructing/ editing letters of response/ justification/ declaration and clinical documentation for submission packages in accordance with guidelines checklists.

  • Compile/ review/check material for dossier prior to submission, incorporate feedback from relevant stakeholders.

  • Conduct checks on artworks to ensure in compliance with local regulation.

• Submit product registration applications to local health authorities  according to target submission timelines.
• Liase with and respond to additional requests or queries from health authorities and follow up (when necessary) until approval per target timelines.
• Liase with enternal and external stakeholders/ departments to build rapport and to achieve target outcomes.

2. Comply with regulatory requirements: to maintain validity of existing licenses/ certification/ authorization (e.g, product licenses, manufacturing licenses, establishment license, GDPMD licenses, import/ export license) through timely variations and/ or renewals to ensure supply continuity.

3. Keep abreast of regulatory updates from health authorities in the drugs, cosmetics, and medical device space.

• Assess regulatory updates on impact to business and communicate insights on approach to handle affairs.
• Propose solutions to arising issues.

4. Update and maintain database of regulatory and product registration information.

5. Good maintenance of final submitted documentation and local repository.

6. Ensure compliance with quality procedures stipulated for regulatory affairs, its administartive maintenance, and plan/ suggest improvements to operations.

7. Support any audits or inspections.

8. Guide/ oversee work performance and development of direct report.

9. Provide input for periodic operation metrics/ budget initiatives by managing  operating expenses within approved budget for the year.

10. Handle any other assingment as advised by supervisor.

 

Requirements: 

• Possess a Bachelor Science
• Work experience in regulatory affairs.
• Familiar with drugs/ cosmetics/ medical device regulatory landscape and GxP related matters.
• Proficiency in Microsoft Office Applications and relevant regulatory system software.
• Adopt good practices in documentation and communication.

Perks & Benefits

• Allowance ( mileage,transportation)
• Medical insurance

工作職責：

1、新產品註冊：

• 根據相關監管要求準備和編制註冊檔案，包括：
  

  • 根據指南清單建立/編輯提交包的回應/理由/聲明和臨床文件。

  • 在提交之前編譯/審查/檢查檔案資料，納入相關利害關係人的回饋。

  • 對藝術品進行檢查，以確保符合當地法規。

• 根據目標提交時間表向當地衛生部門提交產品註冊申請。
• 與衛生當局聯絡並回應其他請求或詢問，並跟進（必要時）直至按照目標時間表獲得批准。
• 與內部和外部利害關係人/部門聯絡，建立融洽關係並實現目標成果。

2. 遵守監管要求：透過及時變更和/或更新來維持現有許可證/認證/授權（例如產品許可證、製造許可證、企業許可證、GDPMD許可證、進出口許可證）的有效性，以確保供應連續性。

3. 隨時了解衛生當局在藥品、化妝品和醫療器材領域的最新監管動態。

• 評估監管更新對業務的影響，並就處理事務的方法傳達見解。
• 針對出現的問題提出解決方案。

4.更新和維護監管和產品註冊資訊資料庫。

5. 妥善維護最終提交的文件和本機儲存庫。

6. 確保遵守監管事務、行政維護規定的品質程序，並規劃/建議營運改善。

7. 支持任何審計或檢查。

8. 指導/監督工作績效和直接報告的發展。

9. 透過在年度核准的預算內管理營運費用，為定期營運指標/預算計畫提供輸入。

10. 處理主管建議的任何其他分配。

要求：

• 擁有科學學士學位
• 監管事務方面的工作經驗。
• 熟悉藥品/化妝品/醫療器材監管環境和 GxP 相關事宜。
• 熟練Microsoft Office應用程式和相關監管系統軟體。
• 在文件和溝通方面採用良好的做法。

津貼和福利

• 津貼（里程、交通）
• 醫療保險

✔ QA Technician (CMM)

✔ Aviation Company

✔ Gelang Patah, Johor Bahru

✔ Monday - Friday

✔ Rotational shift (7.30am - 5.00pm | 7.30pm - 5.00pm)

✔ Basic salary up to RM4000

✔ Min 3 years' working experience in running CMM

✔ Able to run CMM programs

✔ Able to perform inspection using measurement tools

 

Job Responsibilities :

• Perform visual & dimensional inspections
• Use judgement in setting up CMM
• Run CMM programs and perform minor program adjustment to run CMM manually
• Interpret drawings and instructions from operations sheets and complex blueprint

 

Requirements :

• At least 3 years' working experience in inspection
• Able to interpret drawing and instruction from operations sheets and complex blueprints
• Able to run CMM programs
• Able to perform inspection using measurement tools
• Knowledgeable in GD&T and FAI
• Able to communicate in English

Benefits :

• Allowance
• Medical & Dental benefits
• Annual salary increment & bonus

Quality Assurance & Quality Control Engineer (QA/QC Engineer)

Requirements:

• Recognized Diploma/Degree in related field
• Experience in working with Contractors
• Relevant experience in Civil/Building, preferably with experience in façade installation works
• Good team player and adaptable to a dynamic environment

Responsibilities:-

• To lead the QA/QC team
• To provide training and coaching to the team members in façade related works.
• To assess each construction process and procedure. Provide feedback and continuous improvement whenevee necessary
• To ensure internal quality controls are in place and being maintained properly
• Work closely with other project personnel such as production and site management team to deliver high quality works
• Prepare monthly analysis and report to Management in regards to site and project activities

The primary role (Suitable for Beginners)

• Web scrapping using HTML and Python on beautiful soup, Sellenium, Pycharm and more
• To check and ensure that the data in the csv. files match what is on the websites and that the code is working and then keeping/storing the csv files into Dropbox

Other roles if not assigned Webscrapping.

• Manual software testing for our website and application and documenting any issues, bugs or errors found as well as any possible solutions for them
• Automation testing using Cypress.io to automate the bug testing process
• AI automation testing using the Recombee platform (Suitable for Machine Learning, AI or Data Science majors)
• Research into the best ways to develop/create/establish a system or element of our platform like chatbots, automated responses, etc if needed
• If needed: Using Adobe XD to open prototype designs and analyze the UI/UX
• If needed: Assisting senior developers by coordinating project management activities using Jira

Note: We mainly use Skype and Dropbox, but with seniors developer you may also have the opportunity to use Microsoft Teams.

The primary role (Suitable for Beginners)

• Web scrapping using HTML and Python on beautiful soup, Sellenium, Pycharm and more
• To check and ensure that the data in the csv. files match what is on the websites and that the code is working and then keeping/storing the csv files into Dropbox

Other roles if not assigned Webscrapping.

• Manual software testing for our website and application and documenting any issues, bugs or errors found as well as any possible solutions for them
• Automation testing using Cypress.io to automate the bug testing process
• AI automation testing using the Recombee platform (Suitable for Machine Learning, AI or Data Science majors)
• Research into the best ways to develop/create/establish a system or element of our platform like chatbots, automated responses, etc if needed
• If needed: Using Adobe XD to open prototype designs and analyze the UI/UX
• If needed: Assisting senior developers by coordinating project management activities using Jira

Note: We mainly use Skype and Dropbox, but with seniors developer you may also have the opportunity to use Microsoft Teams.

The primary role (Suitable for Beginners)

• Web scrapping using HTML and Python on beautiful soup, Sellenium, Pycharm and more
• To check and ensure that the data in the csv. files match what is on the websites and that the code is working and then keeping/storing the csv files into Dropbox

Other roles if not assigned Webscrapping.

• Manual software testing for our website and application and documenting any issues, bugs or errors found as well as any possible solutions for them
• Automation testing using Cypress.io to automate the bug testing process
• AI automation testing using the Recombee platform (Suitable for Machine Learning, AI or Data Science majors)
• Research into the best ways to develop/create/establish a system or element of our platform like chatbots, automated responses, etc if needed
• If needed: Using Adobe XD to open prototype designs and analyze the UI/UX
• If needed: Assisting senior developers by coordinating project management activities using Jira

Note: We mainly use Skype and Dropbox, but with seniors developer you may also have the opportunity to use Microsoft Teams.

The primary role (Suitable for Beginners)

• Web scrapping using HTML and Python on beautiful soup, Sellenium, Pycharm and more
• To check and ensure that the data in the csv. files match what is on the websites and that the code is working and then keeping/storing the csv files into Dropbox

Other roles if not assigned Webscrapping.

• Manual software testing for our website and application and documenting any issues, bugs or errors found as well as any possible solutions for them
• Automation testing using Cypress.io to automate the bug testing process
• AI automation testing using the Recombee platform (Suitable for Machine Learning, AI or Data Science majors)
• Research into the best ways to develop/create/establish a system or element of our platform like chatbots, automated responses, etc if needed
• If needed: Using Adobe XD to open prototype designs and analyze the UI/UX
• If needed: Assisting senior developers by coordinating project management activities using Jira

Note: We mainly use Skype and Dropbox, but with seniors developer you may also have the opportunity to use Microsoft Teams.

The primary role (Suitable for Beginners)

• Web scrapping using HTML and Python on beautiful soup, Sellenium, Pycharm and more
• To check and ensure that the data in the csv. files match what is on the websites and that the code is working and then keeping/storing the csv files into Dropbox

Other roles if not assigned Webscrapping.

• Manual software testing for our website and application and documenting any issues, bugs or errors found as well as any possible solutions for them
• Automation testing using Cypress.io to automate the bug testing process
• AI automation testing using the Recombee platform (Suitable for Machine Learning, AI or Data Science majors)
• Research into the best ways to develop/create/establish a system or element of our platform like chatbots, automated responses, etc if needed
• If needed: Using Adobe XD to open prototype designs and analyze the UI/UX
• If needed: Assisting senior developers by coordinating project management activities using Jira

Note: We mainly use Skype and Dropbox, but with seniors developer you may also have the opportunity to use Microsoft Teams.

The primary role (Suitable for Beginners)

• Web scrapping using HTML and Python on beautiful soup, Sellenium, Pycharm and more
• To check and ensure that the data in the csv. files match what is on the websites and that the code is working and then keeping/storing the csv files into Dropbox

Other roles if not assigned Webscrapping.

• Manual software testing for our website and application and documenting any issues, bugs or errors found as well as any possible solutions for them
• Automation testing using Cypress.io to automate the bug testing process
• AI automation testing using the Recombee platform (Suitable for Machine Learning, AI or Data Science majors)
• Research into the best ways to develop/create/establish a system or element of our platform like chatbots, automated responses, etc if needed
• If needed: Using Adobe XD to open prototype designs and analyze the UI/UX
• If needed: Assisting senior developers by coordinating project management activities using Jira

Note: We mainly use Skype and Dropbox, but with seniors developer you may also have the opportunity to use Microsoft Teams.

The IKEA Food Halal Compliance Manager is responsible for overseeing all aspects of IKEA Food's Halal operations, ensuring compliance with Halal standards and regulations. This role involves a combination of strategic planning, operational execution, and regulatory compliance.

• You will develop and implement halal compliance policies and procedures for all food service outlets in the IKEA stores.
• You will establish HALAL SOP and HALAL ASSURANCE SYSTEM manuals and guidelines.
• You will coordinate with JAKIM, MOH, and other relevant government agencies regarding halal-related matters to meet food safety requirements.
• You will conduct training sessions to ensure food safety, quality, and regulatory compliance.
• You will manage customer complaints and conduct QA investigations.
• You will address Non-conformance (Corrective Action) related to Halal matters promptly and provide timely justifications.
• You will keep store and country management informed about any changes regarding Halal certification.
• You will review the Halal Assurance System to ensure information is up to date.
• You will ensure all food and beverage supplies are halal and registered with MYeHALAL.
• You will prepare documents and reports for HALAL committee meetings.
• You will maintain the HALAL files and documents, ensuring they are well-organized and up to date.
• You will conduct external and internal halal audits to monitor halal quality and oversee internal halal training to promote knowledge and awareness of halal practices in the food and beverage industry.

The primary role (Suitable for Beginners)

• Web scrapping using HTML and Python on beautiful soup, Sellenium, Pycharm and more
• To check and ensure that the data in the csv. files match what is on the websites and that the code is working and then keeping/storing the csv files into Dropbox

Other roles if not assigned Webscrapping.

• Manual software testing for our website and application and documenting any issues, bugs or errors found as well as any possible solutions for them
• Automation testing using Cypress.io to automate the bug testing process
• AI automation testing using the Recombee platform (Suitable for Machine Learning, AI or Data Science majors)
• Research into the best ways to develop/create/establish a system or element of our platform like chatbots, automated responses, etc if needed
• If needed: Using Adobe XD to open prototype designs and analyze the UI/UX
• If needed: Assisting senior developers by coordinating project management activities using Jira

Note: We mainly use Skype and Dropbox, but with seniors developer you may also have the opportunity to use Microsoft Teams.

PURPOSE OF JOB

Working in a corporate headquarters environment, you will be a Customer to factory liaison position responsible for the assurance of product quality and the maintenance of the QMS.

The individual will work closely with WEO manufacturing sites to ensure product quality is sustained throughout the manufacturing lifecycle of the product. You will facilitate the assessment, identification, correction, and prevention of quality issues via risk analysis and root cause analysis tools.

Reporting to the department head, you will assist in the planning and execution of the corporate quality strategy and tactical action plans rollout. You will be responsible for quality planning and establishing and maintaining metrics to improve quality system processes, process capability, reliability, and quality of the products.

JOB DUTIES

Primary Job Duties:

Incoming / Supplier Quality:

• Planning of inspection / lead reduction of incoming activities at HQ via factory direct shipment initiative

• Coordinate investigation of quality issues with supply chain, factory/supplier

• Coordinate MRB review meeting to ensure NCMR are investigate and processed in a timely manner

• Participate in supplier qualification process / performance trending

• Review and prepare inspection reports for shipment

• Lead supplier audit programme

NPI / First Article Inspection & Qualification:

• Participate in NPI / FA drawing review meetings with factory to align test acceptance criteria and inspection test plans

• Support inspection correlation activities between customer and factory as necessary

• Support FA source inspection, review FA documentation for completeness and submit FA package for Qualification

• Conduct review meeting to ensure completeness of manufacturing documentation after FA Qualification approval

Quality Improvement / Complaint handling

• liaison between customer and factory/supplier on quality issues

• support investigation & root cause analysis

• follow up and ensure timely closure of CAPA/SCAR

NPI / First Article Qualification:

• Participate in NPI / FA drawing review meetings with factory to align test acceptance criteria and inspection test plans

• Support inspection correlation activities between customer and factory

• Support FA source inspection, review FA documentation for completeness and submit FA package for Qualification

• Conduct review meeting to ensure completeness of manufacturing documentation after FA Qualification approval

Quality Improvement / Complaint handling:

• Liaison between customer and factory/supplier on quality issues and support recovery plan

• Coordinate investigation and root cause analysis

• Verification of effectiveness and ensure timely closure of CAPA/SCAR

• Execute quality improvement action plan

• Participate in customer weekly meetings

Quality Management System / Continuous improvement:

• Support the implementation and maintenance of QMS according to ISO 9001 requirements

• Lead preparation and handling of customer audits

• Lead improvement / project rollouts

CANDIDATE REQUIREMENTS

Experience:

• 8 years experience in an Optics / Manufacturing / Precision Engineering environment

Qualifications:

• Degree in Mechanical Engineering or equivalent

Other Requirements:

• Proficient in English and Chinese language to communicate with customers from Asia, Europe, and USA

• Able to travel to China and Malaysia to support business needs

Key Competencies Required For the Job

• Experienced in the field of Optics / Manufacturing / Precision Engineering environment

• Good understanding in the implementation of QMS (ISO 9001/13485), Quality Assurance and Quality Control methodology

• ISO 9001:2015 Internal Auditor Trained

• Strong understanding in the use of Quality & Process Controls tools (CAPA, 5 Why, Risk assessment, control plan, SPC, metrology, and inspection techniques)

• Able to interpret Engineering drawings

• Critical thinker, Independent, resourceful, and motivated to pick up new skills

PURPOSE OF JOB

Working in a corporate headquarters environment, you will be a Customer to factory liaison position responsible for the assurance of product quality and the maintenance of the QMS.

The individual will work closely with WEO manufacturing sites to ensure product quality is sustained throughout the manufacturing lifecycle of the product. You will facilitate the assessment, identification, correction, and prevention of quality issues via risk analysis and root cause analysis tools.

Reporting to the department head, you will assist in the planning and execution of the corporate quality strategy and tactical action plans rollout. You will be responsible for quality planning and establishing and maintaining metrics to improve quality system processes, process capability, reliability, and quality of the products.

JOB DUTIES

Primary Job Duties:

Incoming / Supplier Quality:

• Planning of inspection / lead reduction of incoming activities at HQ via factory direct shipment initiative

• Coordinate investigation of quality issues with supply chain, factory/supplier

• Coordinate MRB review meeting to ensure NCMR are investigate and processed in a timely manner

• Participate in supplier qualification process / performance trending

• Review and prepare inspection reports for shipment

• Lead supplier audit programme

NPI / First Article Inspection & Qualification:

• Participate in NPI / FA drawing review meetings with factory to align test acceptance criteria and inspection test plans

• Support inspection correlation activities between customer and factory as necessary

• Support FA source inspection, review FA documentation for completeness and submit FA package for Qualification

• Conduct review meeting to ensure completeness of manufacturing documentation after FA Qualification approval

Quality Improvement / Complaint handling

• liaison between customer and factory/supplier on quality issues

• support investigation & root cause analysis

• follow up and ensure timely closure of CAPA/SCAR

NPI / First Article Qualification:

• Participate in NPI / FA drawing review meetings with factory to align test acceptance criteria and inspection test plans

• Support inspection correlation activities between customer and factory

• Support FA source inspection, review FA documentation for completeness and submit FA package for Qualification

• Conduct review meeting to ensure completeness of manufacturing documentation after FA Qualification approval

Quality Improvement / Complaint handling:

• Liaison between customer and factory/supplier on quality issues and support recovery plan

• Coordinate investigation and root cause analysis

• Verification of effectiveness and ensure timely closure of CAPA/SCAR

• Execute quality improvement action plan

• Participate in customer weekly meetings

Quality Management System / Continuous improvement:

• Support the implementation and maintenance of QMS according to ISO 9001 requirements

• Lead preparation and handling of customer audits

• Lead improvement / project rollouts

CANDIDATE REQUIREMENTS

Experience:

• 8 years experience in an Optics / Manufacturing / Precision Engineering environment

Qualifications:

• Degree in Mechanical Engineering or equivalent

Other Requirements:

• Proficient in English and Chinese language to communicate with customers from Asia, Europe, and USA

• Able to travel to China and Malaysia to support business needs

Key Competencies Required For the Job

• Experienced in the field of Optics / Manufacturing / Precision Engineering environment

• Good understanding in the implementation of QMS (ISO 9001/13485), Quality Assurance and Quality Control methodology

• ISO 9001:2015 Internal Auditor Trained

• Strong understanding in the use of Quality & Process Controls tools (CAPA, 5 Why, Risk assessment, control plan, SPC, metrology, and inspection techniques)

• Able to interpret Engineering drawings

• Critical thinker, Independent, resourceful, and motivated to pick up new skills

PURPOSE OF JOB

Working in a corporate headquarters environment, you will be a Customer to factory liaison position responsible for the assurance of product quality and the maintenance of the QMS.

The individual will work closely with WEO manufacturing sites to ensure product quality is sustained throughout the manufacturing lifecycle of the product. You will facilitate the assessment, identification, correction, and prevention of quality issues via risk analysis and root cause analysis tools.

Reporting to the department head, you will assist in the planning and execution of the corporate quality strategy and tactical action plans rollout. You will be responsible for quality planning and establishing and maintaining metrics to improve quality system processes, process capability, reliability, and quality of the products.

JOB DUTIES

Primary Job Duties:

Incoming / Supplier Quality:

• Planning of inspection / lead reduction of incoming activities at HQ via factory direct shipment initiative

• Coordinate investigation of quality issues with supply chain, factory/supplier

• Coordinate MRB review meeting to ensure NCMR are investigate and processed in a timely manner

• Participate in supplier qualification process / performance trending

• Review and prepare inspection reports for shipment

• Lead supplier audit programme

NPI / First Article Inspection & Qualification:

• Participate in NPI / FA drawing review meetings with factory to align test acceptance criteria and inspection test plans

• Support inspection correlation activities between customer and factory as necessary

• Support FA source inspection, review FA documentation for completeness and submit FA package for Qualification

• Conduct review meeting to ensure completeness of manufacturing documentation after FA Qualification approval

Quality Improvement / Complaint handling

• liaison between customer and factory/supplier on quality issues

• support investigation & root cause analysis

• follow up and ensure timely closure of CAPA/SCAR

NPI / First Article Qualification:

• Participate in NPI / FA drawing review meetings with factory to align test acceptance criteria and inspection test plans

• Support inspection correlation activities between customer and factory

• Support FA source inspection, review FA documentation for completeness and submit FA package for Qualification

• Conduct review meeting to ensure completeness of manufacturing documentation after FA Qualification approval

Quality Improvement / Complaint handling:

• Liaison between customer and factory/supplier on quality issues and support recovery plan

• Coordinate investigation and root cause analysis

• Verification of effectiveness and ensure timely closure of CAPA/SCAR

• Execute quality improvement action plan

• Participate in customer weekly meetings

Quality Management System / Continuous improvement:

• Support the implementation and maintenance of QMS according to ISO 9001 requirements

• Lead preparation and handling of customer audits

• Lead improvement / project rollouts

CANDIDATE REQUIREMENTS

Experience:

• 8 years experience in an Optics / Manufacturing / Precision Engineering environment

Qualifications:

• Degree in Mechanical Engineering or equivalent

Other Requirements:

• Proficient in English and Chinese language to communicate with customers from Asia, Europe, and USA

• Able to travel to China and Malaysia to support business needs

Key Competencies Required For the Job

• Experienced in the field of Optics / Manufacturing / Precision Engineering environment

• Good understanding in the implementation of QMS (ISO 9001/13485), Quality Assurance and Quality Control methodology

• ISO 9001:2015 Internal Auditor Trained

• Strong understanding in the use of Quality & Process Controls tools (CAPA, 5 Why, Risk assessment, control plan, SPC, metrology, and inspection techniques)

• Able to interpret Engineering drawings

• Critical thinker, Independent, resourceful, and motivated to pick up new skills