Quality Management System Executive
4 days ago
Job Responsibilities:
1. Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, GDPMDS, and other applicable regulations.
2. Ensure compliance with local and international regulatory requirements, including HSA (Health Sciences Authority) regulations for IVD devices in Singapore.
3. Manage documentation processes, including SOPs, work instructions, and records, to ensure accuracy and compliance.
4. Prepare for and participate in internal and external audits, including regulatory inspections and customer audits.
5. Conduct training sessions for employees on quality policies, regulatory updates, and best practices in quality management.
6. Assist in risk assessment and mitigation activities related to product quality and regulatory compliance.
7. Investigate non-conformances, implement corrective and preventive actions (CAPA), and monitor their effectiveness.
8. Support supplier audits and evaluations to ensure adherence to quality standards.
9. Identify opportunities for process improvements and work with teams to enhance efficiency and effectiveness.
Job Requirements
1. Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field.
2. Minimum of 2 years of experience in quality management, regulatory affairs, or related roles within the medical device or IVD industry.
3. Familiarity with ISO 13485, GDPMDS, EU IVDR, FDA QSR, and Singapore's HSA regulations.
4. Skills:
I. Strong understanding of quality management principles and regulatory requirements.
II. Excellent organizational and documentation skills.
III. Strong analytical and problem-solving skills.
IV. Effective communication and teamwork abilities.
VI. Ability to work independently and manage multiple tasks efficiently.
5. Certifications (Preferred): ISO 13485 Lead Auditor or other relevant quality certifications.
Tell employers what skills you haveCAPA
FDA
Risk Assessment
Regulatory Compliance
Quality Management
Ability To Work Independently
Regulatory Affairs
ISO
Documentation Skills
Auditor
Biomedical Engineering
Biotechnology
Audits
Regulatory Requirements
Health Sciences
Life Sciences
-
Quality Assurance Executive
3 weeks ago
Singapore QUALITY MEAT PTE. LTD. Full timeRoles & ResponsibilitiesJob ResponsibilitiesWork closely with all production team on the production process and oversee the day-to-day operations to ensure compliance with AVA, NEA HACCP guidelines and ISO standards Perform the creation and revision of corporate level quality documents that support GMP operations to ensure compliance with GMP guidelines ...
-
Quality Systems Executive
7 days ago
Singapore Awfully Chocolate Pte Ltd Full timeJob Summary:We are looking for a Quality Systems Executive to oversee the implementation and maintenance of our quality management system. The successful candidate will be responsible for ensuring that our quality systems are aligned with international standards and best practices, and that our operations meet regulatory requirements.Main...
-
Quality System Management
1 week ago
Singapore POET TECHNOLOGIES PTE. LTD. Full timeRoles & ResponsibilitiesResponsible for developing the Quality strategy, policies, processes, standards and systems for the Company and its supply chain to operate within. This may include auditing to ensure compliance although this may be carried out by a third-party accredited body. Develop and sustain the Quality Management System in line with the...
-
Engineer, Quality Management System
2 weeks ago
Singapore THE TALENT PEOPLE PTE. LTD. Full timeRoles & ResponsibilitiesSupport the Quality Manager to establish & maintain an effective and best-in-class quality management system & processes in compliance to 21CFR Part 820 QSR, ISO 13485 & ISO 9001 Quality Management System standards, and meeting customers as well as relevant statutory & medical device regulatory requirements.The key roles and...
-
Engineer, Quality Management System
3 weeks ago
Singapore UNIVAC PRECISION ENGINEERING PTE LTD Full timeRoles & ResponsibilitiesAbout the jobVenture, a public listed company in SGX, is a leading global provider of technology services, products and solutions with established capabilities spanning marketing research, design, research and development. Over the years, Venture has built know-how and intellectual property with expertise in several technology...
-
Singapore NATIONAL UNIVERSITY HEALTH SYSTEM PTE. LTD. Full timeRoles & ResponsibilitiesOverviewThe Assistant Manager, will play a crucial role in supporting the development and implementation of quality and safety initiatives within NICQ. This position will provide administrative, project management, and analytical support to the Institute's leadership and team, contributing to the establishment of a robust quality and...
-
Operations Executive
4 days ago
Singapore EXECUTIVE SHIP MANAGEMENT PTE LTD Full timeRoles & ResponsibilitiesExecutive Ship Management (ESM) is a premier ship management company preferred by industry leaders for our superior professional expertise and bespoke services to discerning shipowners.ESM is part of Executive Group, an ensemble of seven maritime service providers, headquartered in Singapore with offices in 11 cities around the world....
-
Senior Quality Systems Specialist
2 hours ago
Singapore GenScript Full timeGenScript OverviewGenScript Biotech Corporation is a global biotechnology leader with a strong presence in North America, Europe, the Greater China, and Asia Pacific. Founded in 2002, our company has established itself as a trusted partner in the life science industry.We offer a comprehensive range of services, including gene synthesis, enzyme and synthetic...
-
Building Management System Manager
4 days ago
Singapore CERTIS INTEGRATED FACILITIES MANAGEMENT PTE. LTD. Full timeRoles & ResponsibilitiesResponsibilities:Oversee and ensure the quality, efficiency, and regulatory compliance of all building system services, including maintenance, emergency response, and improvement projects, delivered by both internal teams and external contractors. Supervise adherence to regulatory requirements, ensuring timely procurement of permits,...
-
Quality Assurance Executive
3 weeks ago
Singapore JADE ENGINEERING PTE. LTD. Full timeRoles & ResponsibilitiesSUMMARY· This position is responsible for monitoring the effectiveness and continuous improvement of the company's quality management system.· The Quality Executive will conduct and lead internal and supplier quality audits.· The Quality Executive will support surveillance audits conducted by certifying authorities / national...
-
Quality Systems Specialist, ACTRIS
2 weeks ago
Singapore CONSORTIUM FOR CLINICAL RESEARCH AND INNOVATION, SINGAPORE PTE. LTD. Full timeRoles & ResponsibilitiesThe Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together six national R&D, clinical translation and service programmes to advance clinical research and innovation for Singapore, and establish important capabilities for a future-ready healthcare system.The Business Entities under CRIS include:Singapore...
-
Quality Manager
2 weeks ago
Singapore THE TALENT PEOPLE PTE. LTD. Full timeRoles & ResponsibilitiesRoles & ResponsibilitiesThe Quality Assurance Manager plays a crucial role in business by ensuring that products meet certain standards of quality. To directs or coordinates quality assurance programs and formulate quality control policies. Also, work to improve an organisation's efficiency and profitability by reducing waste....
-
Quality Executive
4 days ago
Singapore SANKYU (SINGAPORE) PTE LTD Full timeRoles & ResponsibilitiesDuties & Responsibilities:Oversee and guide the Quality team to ensure effective quality control across the entire warehouse department. Collaborate with the Warehouse Manager to review and refine work instructions, ensuring clear and efficient operational procedures. Plan and conduct education and training programs to enhance the...
-
Building Management System Engineer
4 days ago
Singapore CERTIS INTEGRATED FACILITIES MANAGEMENT PTE. LTD. Full timeRoles & ResponsibilitiesResponsibilities:Ensure the quality, efficiency, and regulatory compliance of all building system services, including maintenance, emergency response, and improvement projects, delivered by both internal teams and external contractors. Supervise adherence to regulatory requirements, ensuring timely procurement of permits, completion...
-
Quality Manager
3 weeks ago
Singapore SINGAPORE AERO ENGINE SERVICES PRIVATE LIMITED Full timeRoles & ResponsibilitiesJob DescriptionProduct SafetyTo provide leadership to the CFT that all work is carried out in compliance with the required standards to ensure conformance to the engineering specifications and requirements of the Company"s Safety Management System and for promoting a product safety culture in the organisation.Safety & QualityTo drive...
-
Project manager
7 days ago
Singapore BTI Executive Search Pte Ltd Full timeProject Manager Singapore, Indonesia Our Client: Our client is an energy solution company specializing in engineering, logistics, and maintenance for offshore marine, manufacturing, and power generation. They are looking for a Project Manager to plan, execute and oversee all infrastructure projects within the oil terminal. This role requires expertise in...
-
system engineer
3 weeks ago
Singapore APTITUDE MANAGEMENT CONSULTING PTE. LTD. Full timeRoles & ResponsibilitiesAMC Founded in 2006, licensed by the Singapore Police Force, Police Licensing and Regulatory Department. offers custom security solutions suited to your demands. We work towards meeting the unique needs of every client, be it an enhancement to your current security set up or a complete overhaul that includes:Virtual patrolling ...
-
SYSTEM ENGINEER
3 weeks ago
Singapore APTITUDE MANAGEMENT CONSULTING PTE. LTD. Full timeRoles & ResponsibilitiesAMC Founded in 2006, licensed by the Singapore Police Force, Police Licensing and Regulatory Department. offers custom security solutions suited to your demands. We work towards meeting the unique needs of every client, be it an enhancement to your current security set up or a complete overhaul that includes: Virtual patrolling ...
-
Quality Assurance Executive
1 day ago
Singapore Recruit Express Pte Ltd Full timeRequirementsMinimum of 2 years of work experience in the pharmaceutical, formulation, or fragrance industry.Strong understanding of quality management systems.Proficient in lab testing and R&D activities related to formulation or fragrance.What We OfferAs a Product Development Executive at Recruit Express Pte Ltd, you will have the opportunity to work on...
-
Management System Auditor
7 days ago
Singapore People Profilers Full timeThe Management System Auditor RoleWe are seeking a highly skilled Management System Auditor to join our team at People Profilers. The successful candidate will be responsible for auditing and evaluating our quality management systems, including establishing and maintaining management systems, planning and executing audits, and developing QA activities.Key...