
Medical Device Auditor
4 days ago
**Tasks**
- We are currently looking for a Medical Auditor to perform the Audits, inspections and trainings for clients to help ensure that our client’s meet the requirements of International requirements.
- This includes the following areas:
- Performing Audits in ISO 13485 / MDD, J-QMS, CMDCAS, MDSAP / Specific medical device standards
- Performing ISO 13485 / MDD / specific medical standards / and GMP inspections
- Performing in-house and public training for clients (e.g. ISO 13485 / MDD / Specific Medical Device Standards / QSR)
- You will be responsible for:
- Conduct audits on clients’ medical device quality systems based on regulatory requirements for access into EU, Japan and Canada
- Assist Sales by providing technical advice to existing and prospective clients and respond to enquiries relating to medical device certification
- Process clients’ queries, Change Notifications, EC certificate extensions and audits effectively within acceptable time frames or when due, including quotations and contract reviews where necessary
- Take charge of pre and post audit tasks including calculation of audit duration, quotations, audit registration, preparation of documentation and submission files & maintain filling of paper and electronics records
- Maintain authorizations for auditing and technical reviews and corresponding objective evidence
- Ensure timely completion of audit/surveillance and submission of audit reports
- Develop and review audit methodologies for accreditation compliance
- Provide support for other departments on day-to-day planning, marketing, operations, and new product development.
- Undergo relevant training, qualification, or certification process to be qualified to provide further services.
- To implement and uphold medical device laws and regulations of the country
- To generate, compile and prepare assessment reports and recommendations for review of certification bodies.
**Qualifications**
- Minimum 5 years of relevant experience in the medical industry, with at least 2 years in Quality Assurance work with manufacturers of medical devices with a relevant Bachelor’s degree.
- Good knowledge of medical device directives, ISO 9001 and ISO 13485 standard will be an added advantage
- Global Regulatory Affairs background, including MDD/IVDD is preferred
- Clear and articulate presentation ability with excellent communication skills
- Travelling will be required within ASEAN, largely Thailand and Malaysia, occasion travel to USA and Europe
-
Asean Medical Device Auditor
3 days ago
Singapore TÜV SÜD PSB Pte. Ltd. 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...
-
Lead Auditor
1 week ago
Singapore SGS INTERNATIONAL CERTIFICATION SERVICES SINGAPORE PTE LTD Full timeConduct third party and second party audit to ensure compliance to relevant medical device quality standards and regulatory requirements. - Ensure complete management of audits from planning, conducting audit, compliance assessment, report generation and timely submission, follow-up audits. - Continual Improvement champion **Specific responsibilities;** -...
-
Office Manager
3 days ago
Singapore Chison Medical Full time**Duties and Responsibilities** Typical duties include but are not limited to: - Manage the daily activities of the company operations. These activities include but are not limited to: Service, Logistics, Warehouse, Import/Export, Accounting, Purchasing, Employee recruitment, Payroll, and Training, Facilities Safety - Develop the standard procedures for...
-
Quality System Compliance Auditor
1 week ago
Singapore Hays Full time**Your new company** Leading company in the Medical Devices industry **Your new role** - Manage all phases of global quality system compliance audits for compliance against US and international regulatory requirements and standards (e.g. FDA and ISO). - Investigate potential compliance issues and advise management proactively; coordinate the resolution of...
-
Medical Devices
2 days ago
Singapore Fairview International School Full timeSenior Business Development Executive, Medical Devices (Singapore)We are seeking motivated and results-driven individuals to join our team as Senior Business Development Executive. In this role, you will be responsible for promoting our medical device brands to medical professionals in Singapore. The Senior Business Development Executive role is ideal for...
-
Medical Device Specialist
1 week ago
Singapore beBeeEngineering Full time $120,000 - $180,000Job Title: Medical Device SpecialistA key contributor to our organization, the Medical Device Specialist will play a pivotal role in designing, developing, and testing medical devices and equipment.Primary Responsibilities:Develop innovative medical devices and equipment, incorporating cutting-edge technologies and materialsEvaluate and analyze data from...
-
Medical Device Regulatory Specialist
3 days ago
Singapore beBeeCompliance Full time $90,000 - $120,000Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to lead our team in ensuring compliance with regulatory requirements. This role involves identifying and staying up-to-date with evolving regulatory landscapes, communicating updates to internal stakeholders, and planning process improvements.Key ResponsibilitiesRegulatory Compliance:...
-
Medical Device Assembler
1 week ago
Singapore beBeeAssembly Full time $1,600 - $2,600Job Overview:A skilled assembler is required to work in a medical device manufacturing environment. This role involves the assembly and quality checking of medical devices using microscopes.Key Responsibilities:Assemble medical devicesQuality check medical devices using microscopesRequirements:To be successful in this role, you will need to have the...
-
Medical Device Specialist
5 days ago
Singapore beBeeMaintenance Full timeJob Overview: The primary objective of this role is to ensure the maintenance of medical devices adhering to GDPMDS standards, while fostering strong relationships with customers and colleagues. Key Responsibilities: 1. Perform routine maintenance tasks on medical devices as per established protocols and guidelines. 2. Develop and maintain effective...
-
Medical Device Specialist
7 days ago
Singapore beBeeMaintenance Full time $50,000 - $70,000Job Overview:The primary objective of this role is to ensure the maintenance of medical devices adhering to GDPMDS standards, while fostering strong relationships with customers and colleagues.Key Responsibilities:1. Perform routine maintenance tasks on medical devices as per established protocols and guidelines.2. Develop and maintain effective...