27 Iso 13485 Jobs - July 2026 - Urgent Hiring
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"iso 13485"
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Quality Assurance Executive
MYR3,000 - MYR5,000 Per Month
- Maintain and ensure compliance with the company's Quality Management System (QMS) and ISO requirements.
- Handle customer complaints, perform root cause analysis and implement corrective and preventive actions (CAPA).
- Prepare and submit quality reports, including 8D reports and customer complaint reports. Coordinate internal, external and customer audits and follow up on audit findings. ...
ISO 9001 Quality Management System
ISO 13485
Skills Required
ISO 9001 Quality Management System
ISO 13485
customer complaints
quality investigations
corrective and preventive actions (CAPA)
8D Report
Root Cause Analysis (RCA)
FMEA
SPC
5 Why Analysis
internal audits
external/customer audits
precision machining
CNC processes
engineering drawings
GD&T
dimensional inspection methods
Vernier Caliper
Micrometer
Height Gauge
CMM
communication
problem-solving
+21
Posted
2 days ago
Chat Available
You can chat with the employer only after applying for this job.
MYR3,500 - MYR5,000 Per Month
Fresh Graduates
- The Field Staff shall perform the following duties and responsibilities for the Company:1.Review and approve all Equipment Qualification documentations.2.Work with cross functional team to resolve quality issues related to non-device software and any discrepancies occur during qualification.3.Ensuring compliance company procedures, applicable regulatory requirements and industry standards.4.Support other Software Quality related processes such as non-device software related NCEP/CAPA, and risk management. Participate in meetings and discussions related to non-device software validation.
Quality Control
Quality Assurance (QA)
Skills Required
Quality Control
Quality Assurance (QA)
Data Quality
+1
Be an early applicant!
Posted
7 days ago
EA RECRUITMENT PTE LTD
SGD2,000 - SGD7,000 Per Month
Boon Lay
- Conduct assessment and review on supplier qualification, performance and process capability
- Ensure supplier quality issues are deal with, analysed, improved and follow through
- Collect, handle and follow-up on customer feedback/complaints ...
Posted
4 days ago
SGD5,500 - SGD5,500 Per Month
Singapore
- Determine whether products are classified as medical devices and identify appropriate regulatory pathways and risk classifications
- Prepare and submit regulatory applications including product registrations, renewals, and change notifications to relevant authorities
- Follow up on submissions and address authority feedback to support successful approvals ...
Posted
9 days ago
SGD5,500 - SGD5,500 Per Month
Singapore
- Determine whether products are classified as medical devices and identify appropriate regulatory pathways and risk classifications
- Prepare and submit regulatory applications including product registrations, renewals, and change notifications to relevant authorities
- Follow up on submissions and address authority feedback to support successful approvals ...
Posted
7 days ago
SGD5,500 - SGD5,500 Per Month
Singapore
- Determine whether products are classified as medical devices and identify appropriate regulatory pathways and risk classifications
- Prepare and submit regulatory applications including product registrations, renewals, and change notifications to relevant authorities
- Follow up on submissions and address authority feedback to support successful approvals ...
Posted
16 days ago
SGD5,500 - SGD5,500 Per Month
Singapore
- Determine whether products are classified as medical devices and identify appropriate regulatory pathways and risk classifications
- Prepare and submit regulatory applications including product registrations, renewals, and change notifications to relevant authorities
- Follow up on submissions and address authority feedback to support successful approvals ...
Posted
17 days ago
SGD4,000 - SGD4,000 Per Month
Singapore
- Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
- Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
- Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness. ...
Posted
3 days ago
SGD4,000 - SGD5,200 Per Month
Islandwide (Singapore)
- Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
- Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
- Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness. ...
Posted
4 days ago
SGD4,000 - SGD4,000 Per Month
Singapore
- Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
- Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
- Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness. ...
Posted
6 days ago
SGD4,000 - SGD4,000 Per Month
Singapore
- Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
- Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
- Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness. ...
Posted
7 days ago
SGD4,000 - SGD4,000 Per Month
Singapore
- Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
- Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
- Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness. ...
Posted
7 days ago
SGD4,000 - SGD4,000 Per Month
Singapore
- Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
- Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
- Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness. ...
Posted
9 days ago
SGD4,000 - SGD4,000 Per Month
Singapore
- Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
- Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
- Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness. ...
Posted
10 days ago
SGD4,000 - SGD4,000 Per Month
Singapore
- Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
- Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
- Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness. ...
Posted
13 days ago
SGD4,000 - SGD4,000 Per Month
Singapore
- Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
- Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
- Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness. ...
Posted
14 days ago
SGD4,000 - SGD4,000 Per Month
Singapore
- Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
- Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
- Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness. ...
Posted
15 days ago
SGD4,000 - SGD4,000 Per Month
Singapore
- Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
- Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
- Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness. ...
Posted
16 days ago
SGD4,000 - SGD4,000 Per Month
Singapore
- Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
- Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
- Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness. ...
Posted
17 days ago
SGD5,500 - SGD5,500 Per Month
Singapore
- Determine whether products are classified as medical devices and identify appropriate regulatory pathways and risk classifications
- Prepare and submit regulatory applications including product registrations, renewals, and change notifications to relevant authorities
- Follow up on submissions and address authority feedback to support successful approvals ...
Posted
3 days ago
SGD3,500 - SGD3,500 Per Month
Singapore
- Lead and implement technical testing methods to ensure compliance with regulatory standards for medical device and pharmaceutical products, including those outlined in USP, for markets in the US, EU, and China.
- Supervise a team of chemists across R&D, Technology Transfer, and Projects, emphasizing experience in Product Development and the ability to deliver cost-effective, reliable technologies for sterile medical device production, ophthalmic solutions, and related products.
- Lead technology transfers and projects, ensuring smooth transitions from lab-scale research to R&D scale and eventually to plant scale. ...
Posted
6 days ago
SGD4,000 - SGD4,000 Per Month
Singapore
- Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
- Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
- Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness. ...
Posted
18 days ago
SGD4,000 - SGD4,000 Per Month
Singapore
- Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
- Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
- Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness. ...
Posted
20 days ago
SGD3,500 - SGD3,500 Per Month
Singapore
- Lead and implement technical testing methods to ensure compliance with regulatory standards for medical device and pharmaceutical products, including those outlined in USP, for markets in the US, EU, and China.
- Supervise a team of chemists across R&D, Technology Transfer, and Projects, emphasizing experience in Product Development and the ability to deliver cost-effective, reliable technologies for sterile medical device production, ophthalmic solutions, and related products.
- Lead technology transfers and projects, ensuring smooth transitions from lab-scale research to R&D scale and eventually to plant scale. ...
Posted
13 days ago
SGD4,000 - SGD4,000 Per Month
Singapore
- Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
- Manage controlled documentation, including procedures, work instructions, specifications, and technical records.
- Plan, coordinate, and conduct internal audits to ensure compliance and audit readiness. ...
Posted
21 days ago
SGD3,500 - SGD3,500 Per Month
Singapore
- Lead and implement technical testing methods to ensure compliance with regulatory standards for medical device and pharmaceutical products, including those outlined in USP, for markets in the US, EU, and China.
- Supervise a team of chemists across R&D, Technology Transfer, and Projects, emphasizing experience in Product Development and the ability to deliver cost-effective, reliable technologies for sterile medical device production, ophthalmic solutions, and related products.
- Lead technology transfers and projects, ensuring smooth transitions from lab-scale research to R&D scale and eventually to plant scale. ...
Posted
20 days ago
SGD3,500 - SGD3,500 Per Month
Singapore
- Lead and implement technical testing methods to ensure compliance with regulatory standards for medical device and pharmaceutical products, including those outlined in USP, for markets in the US, EU, and China.
- Supervise a team of chemists across R&D, Technology Transfer, and Projects, emphasizing experience in Product Development and the ability to deliver cost-effective, reliable technologies for sterile medical device production, ophthalmic solutions, and related products.
- Lead technology transfers and projects, ensuring smooth transitions from lab-scale research to R&D scale and eventually to plant scale. ...
Posted
a month ago
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