Total 12 quality assurance job vacancies in D19 Serangoon Garden, Hougang, Sengkang, Punggol

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.

As a Non-Volatile Memory Quality & Reliability Assurance (NVMQRA) Engineer at Micron Technology, you will be responsible for performing formal Failure Analysis of customer reported failing devices via the Returned Material Authorization (RMA) process. You will be required to summarize lab analysis results at the electrical and physical level to identify root cause and establish an associated containment plan. In this role, you will have the opportunities to collaborate with various engineering and manufacturing stakeholders to evaluate and review Corrective Actions /Preventive Actions. You will provide documentation of the RMA findings and oversee the final customer report till closure. In addition, for the senior role, you will be asked to provide guidance and lead the team when solving complex unplanned deviations reported by our customers. Project management skills are necessary and the ability to make critical decisions that directly translate to quality and timely completion of the project is highly desirable. You will also be required to spearhead the sustaining efforts and keeping up to date on new product knowledge, as well as developing and mentoring new talents.

Responsibilities and Tasks

Perform Failure Analysis of Customer Returns

• Understand customer complaint of the memory component failure
• Initiate communication with Micron Customer-facing team for further details on customer complaint, requesting additional questions to provide best opportunity for successful analysis
• Perform bench level analysis including initial data image analyis/examination
• Perform Automated Test Equipment (ATE) analysis and interpret results
• Work with the appropriate engineering teams (e.g., PE, PYE) to perform detailed fault isolation when electrical failure has been confirmed
• Summarize findings and submit for physical failure analysis (PFA).

Provide FA Reports for Micron Customer Facing Team for Communication to External Customers

• Summarize analysis at electrical and physical level into customer friendly formats.
• Work with the appropriate manufacturing Global Quality teams through the appropriate request systems (example: GPSS) for Root Cause and/or Corrective Action and a containment plan
• Identify potential risk to external customers
• Communicate with respective BU (Business Unit) on potential impact to customers
• Communicate FA updates through interim reports or during scheduled meetings with the customers.
• Provide formal FA Report with findings

Sustain Knowledge of Device Capabilities and Characteristics

• Keep up to date with latest Fab/ASM process technology
• Understand datasheet specifications for each device and the differences from previous technode for NOR * NAND product family
• Comprehension of qualification data and potential impact to customer operation
• Stay up-to-date on common customer applications and usage model
• Partnering with customer support team to resolve ongoing customer issues

Qualifications and Experience

• Excellent verbal and written communication skills in English. The ability to communicate clearly and concisely both verbally and in writing is critical in this role.
• Good organization skills and ability to multitask and coordinate between multiple issue at any given time.
• Ability to work effectively in cross-functional teams and handle pressure situations in a professional manner
• Excellent problem-solving and analytical skills with strong attention to details.
• Familiarity with NexTest /Teradyne bench analytical tools, scripting in linux console will be an added advantage.

Candidates with 2-3 years of experience in the semiconductor industry as Product or QA engineer are preferred. Relevant experienced candidates will be considered for the Senior Role.

Education

A Bachelor or Masters Degree in Electrical Engineering or similar field of study.

The primary responsibility of this position is to provide leadership for all Quality Assurance & Control matters.

This includes:

• Assuring consistent quality of production by developing processes and enforcing compliance to ISO 13485 quality system.
• Validating the production & inspection processes and maintaining validation status
• Managing the records for Quality Inspection, Quality Control, Calibration, QA Lab equipment, Training Resources, ERP Quality Module and Quality System Documentation.
• Managing a team of Engineers, QA Technicians & Quality Inspectors

The incumbent reports to the Site Leader, Singapore and Global Head of Quality (Medevio).

Roles & Responsibilties

Quality System Management

• Manage and maintain the site's quality management system (QMS) in compliance with ISO 13485 and ISO 9001 and applicable regulatory standards.
• Key stakeholder in ERP in Quality Module and DMS of site
• Ensure that the QMS effectively supports all manufacturing and operational processes, resulting in consistently high-quality product outputs.

Quality Operation & Lab Management:

• Oversee the day-to-day operations of the quality control and assurance, ensuring proper procedures and outcomes that consistently align with product specifications.
• Manage a team on quality inspection and establishing protocols fulfilling both internal, external customers.
• Develop and enforce rigorous lab testing protocols to maintain stringent quality and safety standards.

Capital Expenditure Planning and Equipment Management:

• Plan and manage capital expenditure for quality-related equipment in production to support ongoing and new operations.
• Site calibration SME and coordinator for both internal and external calibration.
• Ensure timely maintenance and calibration of quality equipment to maintain operational efficiency and compliance with industry standards.

NPI and quality engineering:

• Ensure compliance with new and pre-existing product requirements.
• Key stakeholder in new product development including qualification to production readiness.

Global Quality:

• Working with Global Head of Quality to drive Global Quality Plan
• Working with peers in Global Quality to drive strategic global initiatives, ensuring cohesive quality management across Medevio Sites

Regulatory Compliance and Auditing:

• Oversee readiness for all internal and external audits, including customer audits and third-party regulatory audits.
• Lead the preparation and submission of documentation required for regulatory compliance in all markets where products are distributed.
• Develop and implement strategies to manage and reduce compliance risks.

Supplier Management and Incoming Quality Control:

• Oversee supplier quality management, conducting audits and addressing issues to ensure supplier compliance with quality standards.
• Develop and maintain strong relationships with suppliers to ensure continuous supply chain improvement and adherence to quality specifications.

Quality Improvement Initiatives:

• Identify opportunities for process improvements and lead quality improvement projects to enhance manufacturing efficacy and product quality.
• Drive the transformation towards a paperless factory to enhance operational efficiency and data integrity.
• Implement Statistical Process Control (SPC) to monitor and control quality during manufacturing processes.
• Utilize digital tools and methodologies such as Six Sigma and lean manufacturing to improve productivity and product quality.

Team Leadership and Development:

• Manage and lead a team of skilled quality engineers and technicians, providing strategic direction, training, and development.
• Foster a culture that prioritizes quality and compliance through continuous training, learning and development programs, and succession planning.

Stakeholder Engagement and Reporting:

• Align with the global quality function on strategic global initiatives, ensuring cohesive quality management across the organization.
• Collaborate closely with manufacturing, R&D, and supply chain departments to ensure alignment on quality standards and to address quality issues promptly.
• Report on quality metrics and KPIs to senior management, providing insights and recommendations for ongoing quality enhancements.
• Communicate effectively with customers and regulatory bodies regarding product quality and compliance issues.

Complaint and CAPA Handling:

• Lead the investigation and resolution of non-conformance issues and product incidents, identifying root causes and implementing corrective actions.
• Manage the customer complaint process, ensuring all complaints are addressed promptly and effectively.
• Lead the development and completion of 8D reports, ensuring thorough documentation and effective resolution of issues.
• Oversee the implementation of corrective and preventive actions (CAPA) to eliminate the causes of potential non-conformities or issues, preventing their recurrence.

Environmental Health and Safety (EHS) and Sustainability:

• Support the development, implementation, and enforcement of an EHS policy, complying with all legal and corporate policies.
• Assist in fostering a culture of safety responsibility, providing ongoing training and resources to ensure a safe and healthy work environment.
• Support the establishment and execution of site ESG goals in alignment with Medevio's global sustainability roadmap, ensuring the site contributes effectively to broader corporate sustainability targets.

Qualifications

• Bachelor’s in Engineering or Science / Master’s in Engineering or Science
• Extensive experience within a manufacturing environment with a thorough understanding of ISO 13485 and ISO 9001.
• Six Sigma certification and/or ASQ certified Quality Engineer

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.

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.

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.

1. Perform daily periodic checks of Central Kitchen to ensure compliance to in-house GMP/GHP standards, SOP, Product Specifications, etc.

2. Conduct random checks on incoming raw materials, and perform product cutting on raw materials to ensure goods received are within in-house specifications.

3. Ensure Process Verification and Validation exercise are completed (i.e. SOP/CCP verification, new product launch process observation, monthly facility checks, monthly traceability exercise, finished goods shelf-life verification, etc.)

4. Conduct investigations on product/process non-conformance (on-line and customer complaints) and follow-up on proposed corrective/preventive measures to ensure effectiveness.

5. Promptly follow-up with contractors (chemical/pest control) during routine servicing to ensure work orders are conducted as per contract.

6. Participate and engage in quality system implementation (audit activities by regulatory/certification bodies and customers).

7. Conduct data/trend analysis on non-conformity of raw material/finished goods, pest reporting statistics, monthly production and facility check statistics, etc. for process and quality improvement.

8. Ensure analysis of food products via microbiological and physical testing, calibration of lab equipment and measurement tools, internal sensory evaluation are conducted as per schedule.

9. Report all non-conformances, discrepancies and/or deviations, and follow-up on the investigation of the non-conformity results.

10. Other projects as assigned.

1. Perform daily periodic checks of Central Kitchen to ensure compliance to in-house GMP/GHP standards, SOP, Product Specifications, etc.

2. Conduct random checks on incoming raw materials, and perform product cutting on raw materials to ensure goods received are within in-house specifications.

3. Ensure Process Verification and Validation exercise are completed (i.e. SOP/CCP verification, new product launch process observation, monthly facility checks, monthly traceability exercise, finished goods shelf-life verification, etc.)

4. Conduct investigations on product/process non-conformance (on-line and customer complaints) and follow-up on proposed corrective/preventive measures to ensure effectiveness.

5. Promptly follow-up with contractors (chemical/pest control) during routine servicing to ensure work orders are conducted as per contract.

6. Participate and engage in quality system implementation (audit activities by regulatory/certification bodies and customers).

7. Conduct data/trend analysis on non-conformity of raw material/finished goods, pest reporting statistics, monthly production and facility check statistics, etc. for process and quality improvement.

8. Ensure analysis of food products via microbiological and physical testing, calibration of lab equipment and measurement tools, internal sensory evaluation are conducted as per schedule.

9. Report all non-conformances, discrepancies and/or deviations, and follow-up on the investigation of the non-conformity results.

10. Other projects as assigned.

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

Job Description

• Reporting to Global Category Microcontroller & Memories (MCM), strive to secure “Best in Class” consistent and sustainable supplier quality performance to reach the Continental Business and Quality targets.
• Maintenance of the defined Supplier Quality Management System (procedures, guidelines, and tools) to ensure the requested quality is in line with the defined supplier management strategies to meet the quality targets.
• Execution of supplier evaluations and assessments to support the cross-functional supplier selection team with the required quality data.
• Driving supplier development & improvement activities at supplier's site.
• Initiation and introduction of the preferred supplier and components strategy.
• Design, initiation, and control of preventive quality management measurements in the design and development phase for supplied parts and services to ensure that our products meet the quality requirements defined.
• Component introduction through robust APQP process which include Component sourcing, writing of specifications, handling of qualifications and risk management.
• Manage change requests (PCN) from component suppliers and assure comprehensive qualification of any change.
• Support of the data system to collect and evaluate supplier quality related key performance indicators (KPIs) for the regular reporting of quality performance.
• Support for the continuous improvement process of all supplier quality-related processes, guidelines, and tools by means of supplier audits, on-site assessments, and benchmarking and best practice sharing programs.

Qualifications

• Degree in Electronics/Electrical Engineering (or related) with minimum 5 years’ experience, preferably in the automotive industry
• Candidates with experience in semiconductor processes (e.g., wafer process technologies, back-end assembly, and testing), knowledge in electronic component & qualification requirements (e.g., AEC-Q, JEDEC, IP qualification) preferred. Candidate with more work experiences may be considered for Principal role.
• Strong experience in quality systems, process audits and part qualification.
• Understanding of automotive practices such as APQP/PPAP/VDA6.3/IATF16949.
• Able to lead suppliers' development and audit activities within Asia.
• Able to work independently and travel frequently (e.g. SE-Asia, China, Japan & S. Korea).
• Strong interpersonal and communication skills e.g. in collaborations, problem solving process, conveying technical details and presentation.

Job Scope

• Operate and maintain production machinery to ensure efficient and safe operation.
• Assist in the preparation of meat products, minimizing waste.
• Pack, weigh, and label completed products according to company standards.
• Maintain a clean and hygienic work environment, including equipment and tools.
• Perform other ad hoc tasks as assigned.
  

Job Requirement

• Ability to work in a fast-paced environment
• Attention to detail and commitment to quality
• Good interpersonal skills

Working Days

6 days

Mondays to Saturdays

Job Scopes

• Keep track and sorting of invoices

- Keep track and look for missing invoices (invoices that are not back yet, invoices that are given back to

customer)

- Print invoices that are not back and pass back to driver for signature and chop.

- Photocopy incorrect invoice for credit notes, debit note and other corrections.

- Make sure the customer and driver sign and chop on the invoices.

- Print missing NTUC invoices, Goods Received Note or Purchase invoice for filing if it is found on the website.

- Modify and print out daily list for invoice sorting.

- Ask for reason as to why the invoices are not back yet.

- Scan invoices requested by customer

• Matching for DFI and NTUC invoices.

a. Update Excel for both DFI and NTUC

b. NTUC

- Photocopy incorrect invoices and print out Purchase Order for Credit note, Debit Note.

- Inform Order desk to ask the customer to reopen or modify purchase order if they are closed, incorrect

or did not open purchase order.

- Scan and submit invoices for matching.

- Look for Purchase order/ Good Received note on the website if the invoice is returned without the

Purchase Order and Good Received note Number/ Attachment.

- Submit the Credit note/Debit note along with invoices.

c. DFI

- Create/modify master list to be submitted to DFI for invoices that needs to be rectify or added in for

matching.

- Photocopy the incorrect invoices and submit to DFI.

- If Credit note is done, ensure the amount is correct and submit.

Requirements

• Minimum relevant diploma qualifications
• Strong communication skills
• Able to multi-task
• Able to work under time pressure
• Fluent in Chinese and English

5.5 working days

8:30am to 5.30pm (Mondays to Fridays)

8.30am to 12.30pm (Saturdays)