Total 6 quality assurance job vacancies in D18 Tampines, Pasir Ris

Responsibilities

• Internal and external excursion management (MRB / Quality Claims)
• Customer data reporting
• Conduct Quality related training
• Support customer survey and audits
• Continuous improvement activities

Requirements

• Bachelor's degree in Engineering or Science.
• Strong systematic and analytical problem-solving abilities.
• Proactive attitude with the ability to handle multiple tasks simultaneously.
• Excellent communication skills and a collaborative team player.
• Understanding of system flow and databases; basic SQL knowledge is advantageous.
  

For Experienced Candidates:

• Proven experience with QA tools such as 8D, FMEA, fishbone diagrams, and AND.
• Solid working knowledge of Statistical Process Control (SPC) and auditing practices.

For Entry-Level Candidates:

• Willingness to learn and adapt to new QA tools and methodologies.
• Basic understanding of quality assurance principles and practices.
• Freshgraduate with part time working experience during Uni time (aside from internship) is a plus.

About Us

Vivo Surgical is a patient-focused, clinician-driven medical device developer and manufacturer. Headquartered in Singapore with offices in China and Thailand, we are pioneering a novel endoscopic surgical robot for complex endoluminal surgeries. ISO 13485 certified with international accreditations awarded such as the US FDA and European CE mark, our devices target the medical needs of the world through innovative applications of science & technology. These encompass such fields as in vivo surgical LED lighting, portable endoscopy and endoscopic robots, which are strategically co-developed with world-class healthcare institutions and KOL collaborators. Join us as we build towards our vision of being Asia Pacific’s leading medical device developer and manufacturer.

About The Role

We value the importance of having a robust Quality Assurance and Regulatory Affairs team that would serve as a key pillar for sustained commercial success. To that end, we are looking for a Quality Assurance & Regulatory Affairs Manager to join us on this journey. You will be part of our fast-growing team and will take ownership of your role from the get-go. You will work on ensuring our company’s commitment to comply with regulatory requirements and to maintain the effectiveness of our Quality Management System (QMS). You will also be in charge of our products’ regulatory strategies and submissions to various regulatory bodies. Your role will enable you to work not only with diverse functions internally but also in close tandem with our external partners such as our suppliers, distributors and notified bodies.

Your responsibilities shall include the following:

• Ensure the company’s QMS complies with ISO 13485 and FDA 21 CFR 820/QMSR.
• Develop and manage Quality Procedures such as document control, CAPA, NCR, Supplier Control, Production Control, Feedback and Complaints Handling, and Post Market Surveillance.
• Organize and execute internal audits, management reviews and supplier audits.
• Plan and lead ISO 13485 audits and regulatory inspections.
• Participate in the products’ verification and validation activities.
• Develop, review and compile the medical device technical files whilst making sure the products meet all regulatory and quality standards.
• Involved in risk assessment tasks to identify potential quality and compliance risks in the product lifecycle and advise adequate risk control measures.
• Serve as the company’s Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC).
• Manage and mentor the QARA team to ensure members are adequately trained.
• Stay updated on medical device laws and regulations in the targeted markets.
• Work with senior management to define and deliver adequate quality and regulatory strategies.

Your Qualifications & Experience

• Minimum Bachelor’s degree in Engineering or Science.
• At least 5 years’ experience in quality assurance and/or regulatory affairs in the medical device Industry.
• Firm understanding of ISO 13485:2016, FDA 21 CFR 820/QMSR and ISO 14971.
• Prior involvement in HSA, FDA 510(k)/De Novo and/or MDR 2017/745 submissions will be a plus.
• Experience in generating risk management documentation (risk management plan, report, FMEAs).
• Possess a leadership and strategic mindset to organize and prioritize tasks for effective and timely delivery of regulatory goals to meet the company’s business objectives.
• Certification as an ISO13485:2016 lead auditor will be advantageous.

Contact

Please send your CV and cover letter to: [email protected]. We look forward to receiving your application.

Job Summary

We seek an experienced and motivated Senior Software Quality Engineer to join our forward-thinking tech team. In this role, you'll ensure our platform is reliable and meets high-quality standards. This position allows you to work across teams, shaping and implementing advanced QA processes that support scalable, reliable, and innovative solutions.

Responsibilities:

Test Strategy and Planning

- Define and lead comprehensive QA strategies, covering all phases of the software development lifecycle.

- Develop, manage, and execute manual and automated test plans, cases, and scripts to ensure thorough testing.

Automation and Tooling

- Lead the development of automated testing frameworks using Cypress, Playwright or any automation tool for end-to-end test coverage.

- Drive platform scalability by implementing performance and load tests using tools like Gatling, K6, or Jmeter.

Quality Assurance

- Perform contract testing to ensure smooth interaction between microservices.

- Lead regression testing efforts for bug fixes and new features to maintain overall quality.

- Oversee the end-to-end testing pipeline, resolving issues promptly to avoid any delays.

Cross-Functional Collaboration

- Work closely with product managers, developers, and DevOps engineers to meet project requirements and deliver high-quality software.

- Contribute to agile team processes, including sprint planning and other ceremonies, with valuable QA insights.

- Coordinate with QE teammates to prepare and lead weekly deployments, ensuring smooth execution.

Issue Resolution and Reporting

- Accurately document, track, and report software defects, conducting root cause analysis as needed.

- Provide timely and detailed reports on QA activities, testing outcomes, and relevant quality metrics.

Mentorship and Leadership

- Mentor junior QA engineers, building a strong team culture focused on quality and continuous improvement.

- Stay up-to-date with emerging QA tools and methods, bringing new ideas to the team.

Job Requirements :

- Expertise in software quality assurance, with a strong focus on automation testing (e.g., Cypress, Playwright).

- Demonstrated experience with performance testing tools such as Gatling and Autocannon.

- Proficient in JavaScript (TypeScript) or Java

- Familiar with frontend and backend technologies (e.g., ReactJS, ExpressJS, Gin-gonic), as well as cloud platforms (AWS, Docker, Kubernetes).

- Knowledgeable in CI/CD tools (e.g., GitLab, ArgoCD) and relational databases (MySQL, PostgreSQL).

- Solid understanding of REST and GraphQL APIs, JWT for authentication, and search technologies like Elasticsearch.

- Exposure to additional testing tools and caching systems like Redis.

- Experience with logging and monitoring platforms such as Splunk or OpenSearch

Qualifications:

- Bachelor’s degree

- Strong problem-solving, analytical, and communication skills.

- Demonstrated leadership skills and comfort working in a fast-paced, agile environment.

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking an experienced Quality Control Analyst with experience in pharmaceutical company/Life Science industries for a role in Singapore.

Key Responsibilities:

• Sample storage and management
• Prepare and support analytical testing
• Analytical testing and documentation
• Perform lab housekeeping activities
• Perform administrative documentation
• Comply with all HSE guidelines
• Detect and report potential accident, risks and propose solutions
• Responsible for participating in initial training and retraining

Qualifications:

• Proficient in English.
• Previous experience working in a laboratory environment in the pharmaceutical industry (quality assurance, production).
• Nitec or Diploma holders

This position is for permanent 12-hr night shift, 2-3-2 basis.

Why PharmEng Technology?

Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.

EEOC Statement

At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.

Job Summary

We seek an experienced and motivated Software Quality Engineer to join our forward-thinking tech team. In this role, you'll ensure our platform is reliable and meets high-quality standards. This position allows you to work across teams, shaping and implementing advanced QA processes that support scalable, reliable, and innovative solutions

Responsibilities:

Test Strategy and Planning

- Define and lead comprehensive QA strategies, covering all phases of the software development lifecycle.

- Develop, manage, and execute manual and automated test plans, cases, and scripts to ensure thorough testing.

Automation and Tooling

- Lead the development of automated testing frameworks using Cypress, Playwright or any automation tool for end-to-end test coverage.

- Drive platform scalability by implementing performance and load tests using tools like Gatling, K6, or Jmeter.

Quality Assurance

- Perform contract testing to ensure smooth interaction between microservices.

- Lead regression testing efforts for bug fixes and new features to maintain overall quality.

- Oversee the end-to-end testing pipeline, resolving issues promptly to avoid any delays.

Cross-Functional Collaboration

- Work closely with product managers, developers, and DevOps engineers to meet project requirements and deliver high-quality software.

- Contribute to agile team processes, including sprint planning and other ceremonies, with valuable QA insights.

- Coordinate with QE teammates to prepare and lead weekly deployments, ensuring smooth execution.

Issue Resolution and Reporting

- Accurately document, track, and report software defects, conducting root cause analysis as needed.

- Provide timely and detailed reports on QA activities, testing outcomes, and relevant quality metrics.

Requirements:

- Expertise in software quality assurance, with a strong focus on automation testing (e.g., Cypress, Playwright).

- Demonstrated experience with performance testing tools such as Gatling and Autocannon.

- Proficient in JavaScript (TypeScript) or Java

- Familiar with frontend and backend technologies (e.g., ReactJS, ExpressJS, Gin-gonic), as well as cloud platforms (AWS, Docker, Kubernetes).

- Knowledgeable in CI/CD tools (e.g., GitLab, ArgoCD) and relational databases (MySQL, PostgreSQL).

- Solid understanding of REST and GraphQL APIs, JWT for authentication, and search technologies like Elasticsearch.

- Exposure to additional testing tools and caching systems like Redis.

- Experience with logging and monitoring platforms such as Splunk or OpenSearch.

Qualifications

- Bachelor’s degree

- Strong problem-solving, analytical, and communication skills.

RESPONSIBILITIES

• The role involves planning, coordinating, and implementing standards development projects under the national standardization programme administered by Enterprise Singapore.
• Provide secretariat support to the Technical Committees and Working Groups. This includes preparation of agendas, meeting minutes, report compilation, drafting of standards, etc.
• Engage and coordinate with the industry, academia, and government organizations to facilitate the development, promotion, and review of Singapore Standards and Technical References.
• Organizing key standard launches events and other outreach events.
• Collaborate with key stakeholders to identify, develop, and launch new standards. This includes conducting consultations and ensuring that standards are aligned with industry needs.
• Assist in the industry and technical research for the development of new/review of standards. Conduct verification studies to identify users of the standards.
• Handle inquiries regarding standards in your area of responsibility, ensuring prompt and accurate responses to stakeholders.

Requirements

• Minimum Diploma qualification in quality and safety / Fresh graduate are welcome to apply
• Preferably with at least three (3) years of relevant work experience in safety or manufacturing related field
• Preferably with secretariat experience
• Min. 3 years of experience in quality, safety or manufacturing industry is advantageous
• Results-oriented and able to manage and execute projects in a team and independently.
• Possess good interpersonal skills and work well with various stakeholders
• Good writing and communication skills.
• Proficiency in Microsoft Word, Excel, PowerPoint, and other productivity tools