Current jobs related to Asean Medical Device Auditor - Shah Alam - TÜV SÜD (Malaysia) Sdn Bhd

  • Medical Device Auditor

    6 days ago

    Shah Alam, Selangor, Malaysia TÜV SÜD AG Full time

    Your career opportunities at the TÜV SÜD GroupConduct audits in accordance to the relevant regulations, quality standards, policies, and other required criteria on the part of the auditor.Ensure timely completion of audit/surveillance and submission of audit report.Develop and review audit methodologies for accreditation compliance.Develop and conduct...

  • Auditor for Medical Devices

    5 days ago

    Shah Alam, Selangor, Malaysia TÜV SÜD AG Full time

    Job Responsibilities:As a medical device auditor, your key responsibilities will include conducting audits in accordance with relevant regulations, quality standards, policies, and other required criteria. You will also ensure timely completion of audit/surveillance and submission of audit reports. In addition, you will develop and review audit methodologies...

  • Medical Device Certification Specialist

    5 days ago

    Shah Alam, Selangor, Malaysia TÜV SÜD AG Full time

    Company Overview:TÜV SÜD AG is a leading provider of testing, inspection, and certification services. As a medical device auditor, you will be part of a team that ensures compliance with regulatory requirements.Job Description:We are seeking an experienced auditor to conduct audits in accordance with relevant regulations, quality standards, policies, and...

  • GDPMD Compliance Auditor

    1 day ago

    Shah Alam, Selangor, Malaysia M Pro Resourszes Full time

    GDPMD Compliance Auditor (Selangor)23/01/2025Job DescriptionKey ResponsibilitiesConduct engaging training sessions on GDPMD (Good Distribution Practice for Medical Devices) compliance requirements.Provide in-depth insights into licensing and regulatory frameworks related to the Malaysian medical device industry.Facilitate hands-on workshops, helping...

  • Medical Device Sales and Marketing Specialist

    2 weeks ago

    Shah Alam, Selangor, Malaysia Körber Pharma Packaging AG Full time

    We are seeking a Medical Device Sales and Marketing Specialist to join our team at Körber Pharma Packaging AG. In this role, you will be responsible for promoting our medical device packaging solutions to healthcare professionals and driving business growth through effective sales and marketing strategies.About the Role:We are looking for a highly motivated...

  • Medical Device Regulatory Affairs Manager

    1 day ago

    Shah Alam, Selangor, Malaysia M Pro Resourszes Full time

    About the RoleThis is an excellent opportunity for a dedicated professional to contribute to the success of M Pro Resourszes by ensuring adherence to GDPMD regulations and standards.The selected candidate will be responsible for conducting training sessions, providing expert insights, facilitating workshops, and supporting participants in their learning...

  • Sales Medical Manager

    6 days ago

    Shah Alam, Malaysia Veritas Medical Healthcare Sdn Bhd Full time

    **SALES MEDICAL EXECUTIVE RESPONSIBILITIES** - Experienced in medical industry, or experienced in selling medical devices, or have experience in working in medical appliances. - Overseeing local and regional sales, promotions and campaigns in hospital, clinics and pharmacy. - Doing door to door visiting for clinics,hospitals and pharmacy. - Present our...

  • Sales Medical Executive

    6 days ago

    Shah Alam, Malaysia Veritas Medical Healthcare Sdn Bhd Full time

    Experienced in medical industry, or experienced in selling medical devices, or have experience in working in medical appliances. - Overseeing local and regional sales, promotions and campaigns in hospital, clinics and pharmacy. - Doing door to door visiting for clinics,hospitals and pharmacy. - Present our product to potential clients, Doctors, director and...

  • Medical Product Specialist

    1 week ago

    Shah Alam, Malaysia Venusys Medical Sdn Bhd Full time

    Responsibilities: - Responsible for achieving the sales objective for specific medical devices portfolio. - Establish and maintain a fruitful long-term relationship with key opinion leaders and decision makers. - Perform business development, prospecting new accounts and market updates. - Work hand in hand with other Product Specialists and support staff to...

  • Quality Assurance Lead for Medical Equipment

    5 days ago

    Shah Alam, Selangor, Malaysia TÜV SÜD AG Full time

    Job Summary:As a medical device auditor, you will play a critical role in ensuring compliance with regulatory requirements. Your key responsibilities will include conducting audits in accordance with relevant regulations, quality standards, policies, and other required criteria. You will also ensure timely completion of audit/surveillance and submission of...

  • Medical Sales Specialist

    3 weeks ago

    Shah Alam, Selangor, Malaysia Infinity Medical Sdn Bhd Full time

    Attractive salary package and commission schemeProfessional career growth in medical & healthcare industryMedical and insurance coverage and miscellaneous allowancesKey Responsibilities:-Responsible for achieving the sales objective for specific medical devices portfolio.Establish and maintain a fruitful long-term relationship with key opinion leaders and...

  • Management System Auditor Lead

    2 days ago

    Shah Alam, Selangor, Malaysia TÜV SÜD AG Full time

    Job DescriptionThe key responsibilities of this role include:Conducting management system audits covering adequacy and compliance requirements of Integrated Management Systems, including ISO 9001, ISO 14001, and OHSAS 18001 or ISO 45001.Ensuring timely completion of audits and submission of audit reports.Conducting assessments in line with accreditation and...

  • Regulatory Compliance Expert

    5 days ago

    Shah Alam, Selangor, Malaysia TÜV SÜD AG Full time

    Key Responsibilities:Conduct audits in accordance with relevant regulations, quality standards, policies, and other required criteria; Ensure timely completion of audit/surveillance and submission of audit reports; Develop and review audit methodologies for accreditation compliance; Develop and conduct related training courses; Provide support for other...

  • Medical Sales Executive

    1 week ago

    Shah Alam, Malaysia N.A.Z MEDICAL SUPPLIES SDN. BHD Full time

    **Requirements**: - Diploma or Degree in any fields. - 1-2 years sales and marketing experiences will be an added advantage. - Excellent interpersonal and communication skills. - Customer service oriented and organized. - Must have a natural ability to engage in business relationships with individuals and groups and a desire to improve these...

  • Repair Specialist

    4 weeks ago

    Shah Alam, Malaysia Times Consult Full time

    **Responsibilities**: - Fully responsible for post-sales complaint/inquiry handling. - Work on repair of faulty instruments from local/overseas customers. - Liaise with Product Specialist Department in case of product feature inquiry after sales. - Maintain a complete log of queries/complaints from customers/distributors, and to build a reusable database...

  • Medical Sales Specialist

    2 weeks ago

    Shah Alam, Malaysia Bits Medical Sdn Bhd Full time

    **Job Highlights**: - Good career advancement. - Attractive salary package based on experience and qualification. - Comprehensive training program will be provided upon commencement of employment. - Commission plus annual sales performance reward. - Statutory contributions and insurance coverage. - Petrol, toll and parking claims. - Good and pleasant...

  • Regulatory Compliance Specialist

    1 day ago

    Shah Alam, Selangor, Malaysia M Pro Resourszes Full time

    Job OverviewM Pro Resourszes is seeking a skilled professional to assume the role of GDPMD Compliance Auditor. This position involves ensuring compliance with Good Distribution Practice for Medical Devices (GDPMD) regulations and standards.The ideal candidate will possess extensive knowledge of GDPMD compliance and Malaysian Medical Device Authority (MDA)...

  • Integrated Management System Auditor

    2 weeks ago

    Shah Alam, Selangor, Malaysia TÜV SÜD AG Full time

    Your career opportunities at the TÜV SÜD GroupThe candidate will be responsible for conducting 3rd party audits to determine the effectiveness of controls and the accuracy of management systems and operations in accordance with a specific management system standard. We welcome candidates who are keen to take up regional exposure and the following key...

  • Compliance Training Expert

    1 day ago

    Shah Alam, Selangor, Malaysia M Pro Resourszes Full time

    Key ResponsibilitiesConduct engaging training sessions on GDPMD compliance requirements, ensuring participants understand the necessary protocols and procedures.Provide expert insights into licensing and regulatory frameworks related to the Malaysian medical device industry, staying up-to-date on current MDA guidelines.Facilitate hands-on workshops to help...

  • Sales Leader-medical Sector

    4 weeks ago

    Shah Alam, Malaysia Worldwide Holdings Full time

    Based at Kapar, Klang **Key Resposibilities** - Develops sales plan for assigned accounts preferably in central / north / southern region and private hospitals. - To keep abreast with the latest market trends and analyse data to develop an effective marketing plan and strategy for the assigned products. - Promote and sell our range of high quality medical...

Asean Medical Device Auditor

2 weeks ago

Shah Alam, Malaysia TÜV SÜD (Malaysia) Sdn Bhd Full time

**Tasks**
- We are currently looking for a Medical Device Auditor to join our Medical and Health Service team You will be performing the audit for medical device manufacturers and ensuring that their Quality Management System (QMS) complies with Medical Devices including the Medical Device Regulation (MDR) / In Vitro Diagnostic Medical Devices Regulation (IVDR) and other QMS certification scheme, where applicable.
- We welcome experts from different medical device industries
- For example:

- IVD (in-vitro diagnostics) instrumentation and / or reagents
- Active devices: active non-implantable surgical devices (Cryoablation, High frequency surgery, High-frequency generator, High-frequency instruments, ablation generators, suction pumps for blood), standalone software, Active Endoscopes, and etc
- Ethylene Oxide Sterilisation or other related sterilization
- Non active devices: EAC 14 (rubber and plastic product) and EAC 12 (chemical)
- ** Key Responsibilities**:

- Perform onsite audits at manufacturer s premises by evaluating their Quality Management Systems in accordance with the requirements of the MDR / IVDR, and other QMS certification schemes such as ISO 13485, ISO 9001 and MDSAP
- Assist Sales personnel by providing technical advice to existing and prospective clients
- Take charge of pre and post audit tasks including preparation of audit documentation and audit package submission

**Qualifications**
- ** Key Requirements**:

- Bachelor s degree in Electrical / Biomedical Engineering, Biomedical Science, Pharmaceutical, Chemical Engineering, Chemical Science, Biotechnology or relevant Sciences
- Have at least 2 years experience in Quality Management Systems environment
- Clear and articulate presentation ability with excellent communication skills
- Travelling will be required