Total 16 quality assurance manager job vacancies in Quality Assurance / Control category in Singapore

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.

Authorities and Responsibilities

1. Responsible for providing directives for the Quality Assurance Department in meeting management objectives.
2. Formulate, implement and evaluate quality strategies programs for the company.
3. Implement and maintain a system of auditing the facility and periodic calibration of test, measuring equipment and tools.
4. Manage customer complaints, corrective and preventive action programs.
5. Administer and manage continuous improvement program for all QA processes.
6. Work closely with auditors, customers, production and suppliers to meet the quality requirements.
7. Manage sub-contractors for on-time supply of treatment process, as well as meeting technical requirement.
8. Review / prepare, administer and implement Quality Assurance Plans, Inspection Test Plans and other Operational procedures in accordance to the technical specifications, customer's surveillance requirements, and good manufacturing / engineering practices, and enforce the same on Operations in their execution.
9. Work closely among inter-department to ensure committed schedules are met in a timely and effectively manner.
10. Review and approve disposition program / action for nonconforming products.
11. Ensure that processes needed for the quality management system are established and implemented.
12. Report to top management on the performance of the quality management system, and note needed improvements.
13. Ensure the promotion of awareness of statutory, regulatory and customer requirements throughout the organization.
14. Ensure and coordinate the implementation of risk assessment and risk control of medical devices

The Quality Assurance Manager plays a crucial role in business by ensuring that products meet certain standards of quality. He/She plans, directs or coordinates quality assurance programs and formulate quality control policies. He/She also works to improve an organisation's efficiency and profitability by reducing waste. He/She prepares and update quality documentation, basing their processes on a recognised standard such as ISO 9000 – Quality Management, published by the International Organisation for Standardisation. He/She supervises teams of inspectors who carry out the detailed assessment of products and their components at different stages of production. He/She recruits and trains supervisors, and provides them with documented quality standards as guidelines for their daily work. He/She also selects quality inspection tools and software to support the inspection team.

Competence Requirements:

• Diploma in Mechanical Engineering / Quality Engineering or equivalent.
• Minimum 6 years of solid experience in Quality Management in similar or related industry and 3 years in management level.
• Good knowledge in implementing and up keeping Quality Management System.
• Strong leadership and good interpersonal skills.
• A team player with strong sense of responsibility to ensure plant effective quality performance.

~ Assist in the implementation of company quality systems.
~ Conduct Quality Assurance audit.
~ Manage cause investigation for non-conformance.
~ Manage company quality systems.
~ Manage departmental activities and deployment.
~ Able to commute between Tuas Plant and Loyang Plant.

• Provide guidance and coach lab technicians.
• Inspects all incoming raw material for compliance according to current standards.
• Conducts periodic checks and analysis on all WIPs.
• Retains finished product samples from production to conduct checks and analysis.
• Assist QA on failure analyses, corrective and preventive action response to customer’s complaint.
• Assist in GMP audits, validation, qualification and change control.
• Assist in maintaining Product Quality and Technical File.
• Write technical papers or reports or prepare standards and specifications for processes, products, or tests.
• Supervisory or leadership experience in QC.
• Knowledge in regulatory requirements such as ISO 13485, compliance with good laboratory practice and cGMP.

Our Client is in the Aviation Industry. Due to their current expansion plan, they are looking for an Quality Engineer to join their team, in hopes of developing the current high performing team. They are located in the East.

Responsibilities;

• Ensure product and process quality by managing the Quality Management System (QMS) in compliance with government regulations, aviation authority standards, and customer requirements.
• Update and refine quality procedures and control instructions to align with operational and regulatory standards.
• Collaborate with customers, vendors, and suppliers to address non-conformance issues.
• Perform root cause analysis and implement corrective actions to reduce poor quality costs.
• Conduct internal audits to evaluate compliance with ISO 9001, AS9100, and NADCAP standards.
• Carry out vendor and on-site audits as required to ensure quality performance.
• Ensure strict adherence to customer and regulatory authority standards and specifications.
• Lead efforts to minimize the cost of poor quality and reduce scrap through effective quality management practices.
• Any ad-hoc duty as assigned

Requirement

• Min Degree in Mechanical or Aeronautical Engineering
• Min 2 years experience in ISO9001 / AS9100 Quality Management System and NADCAP process
• Experience and knowledge in fishbone diagrams, FMEA and 5-whys methodology
• Able to read and interpret technical and blue print drawings

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Recruitpedia Pte. Ltd.

EA License No. 19C9682

EA Reg. No. R21103987 (Yan Yongmao)

COMPANY DESCRIPTION

Beyondsoft International (Singapore) Pte. Ltd. was set up in 2007 and established as the regional headquarters for the Southeast Asia (SEA) and European markets in September 2015. Based on our vision of "Using technology to promote social progress, economic development and become a global customer preferred partner" and our concept of "Beyond your expectations", Beyondsoft is committed to provide our customers in countries along the "Belt and Road" with comprehensive solutions and products and creating commercial value for customers to realizing continuous businesses development.

Our core business includes:

1. IT development services providing customers with IT consulting, software research and development, software and hardware testing, system integration and operation and maintenance, data analysis and other services;
2. New retail solutions and products through intelligent products, helping small and medium-sized enterprises (SMEs) realize the digital transformation of their daily operations;
3. Internet of Things (IoT) platform and solutions comprehensive use of IoT, artificial intelligence, big data, cloud computing and other technologies to provide IoT solutions for intelligent upgrades in cities, parks, buildings and industries, to create a smart future.

For more information, please visit www.beyondsoft.com.

RESPONSIBILITIES

• To understand quality requirements and standards and verify conformance in production line.
• To analyse audit findings to minimise process non-conformances in the production line.
• To accurately record and communicate observations from audit/inspection to affected parties and team.
• To inspect sub-assemblies and finished product, both visually and functionally.
• To work in factory environment, which will involve walking around with appropriate attire and safety PPE.
• To observe required factory and safety rules, when performing daily duties.
• To provide accurate reports to engineers and managers on a timely basis.
• To provide suggestions for improvements or highlight challenges encountered.

• Minimum ITE certification with at least 1 year of experience.
• Proficient in Microsoft Excel, Word, PowerPoint, and Outlook.
• Able to work independently with minimal supervision.
• Willing to learn new skills, with passion for quality.
• Troubleshooting skill knowledge will be an advantage.

Our client is a private hospital and we are looking to expand our team!

• To collaborate with Education and Training Department, department’s Nurse Managers/Clinician and other healthcare professionals in the development of on-the- job training and nursing-related clinical competencies, Standard Operating Procedures (SOPs) and Work Instructions
• Assist in providing initial and ongoing on-the-job training for nurses in the respective department.
• To perform clinical supervision and support newly employed nurses in the respective department.
• Act as a resource person to nurses on clinical and nursing quality-related matters.
• Enhance professional nursing development in respective department through continuous mentoring, coaching and role modeling.
• To assist Nursing Quality in the management of Nursing Quality issues as to ensure high standards of nursing practice at the respective department.
• To promote a culture of safety, quality and service excellence by constant monitoring of compliances.
• To participate in nursing quality improvement-related projects.
• To participate in physician rounds and collaborate with physicians and other allie healthcare professionals so as to ensure continuity of patient care.
• To ensure correct billing of consumables used for patients.
• To perform other assignments as and when required by the Nurse Manager/Clinician.

Requirements:

• Possess a valid SNB Registered Nurse Practising Certificate.
• Diploma/Degree in Nursing with a strong clinical nursing background.
• Advanced Diploma in Nursing (Orthopedic, Oncology, Med-surg)
• Clinical Instructor certificate is preferred.
• Possess a valid BCLS and AED certificate.
• Minimum 5 years of Clinical experience
• Able to commit to morning and afternoon shifts

We love building HR software. And surely we can do better – with your help.

What We Value:

• You have initiative and are innovative
• You seek ownership in your work
• You have passion and ambition
• You love challenges and look for responsibilities
• You have a sense of humour (we love a good joke)
• You possess good English written and spoken communication skills

Responsibilities

• Create, maintain, and execute automated regression test suite for mobile and web applications
• Develop and maintain test plans, testing strategies, test cases, test data, matrices, and other QA related documentation
• Work with the Engineering Team to continuously improve test coverage to improve quality of released products
• Keep up to date on the latest tools, industry trends and technologies for software testing and put them to good use!

Requirements

• Degree/Diploma in Information Technology, Computer Engineering, Computer Science or related fields
• MUST HAVE:

1. At least one (1) year of experience in test automation experience
2. At least one (1) year of experience working in an agile environment.
3. Familiar with at least 1 test automation tool software (e.g. testsigma, selenium, Telerik, etc.)
4. Strong understanding of Software QA methodologies best practices to design, build and execute unit, functional and integration test cases
5. An independent, resourceful, result-oriented and analytical thinker.
6. Experience with Git and Jira
7. Strong oral and written English communication skills

We appreciate people who are constantly working towards improving themselves. If you ever find yourself facing an issue, as a team, we’ll find the solutions together.

When’s a better time to join HerdHR and shape the product of the future? We say NOW.

NOTICE

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Our client is a well-established MNC, market leader in the 3PL Logistics industry. Due to their current expansion plan, they are looking for Quality Executive, in hopes of developing the current high performing team. They are located in the East - easily assessible.

Responsibilities:

• Conduct daily meetings to address logistics-related manufacturing NCs.
• Validate defects with QC support, providing corrective action recommendations.
• Resolve logistics issues with proper containment and corrective measures.
• Manage complaints, perform root cause analysis, and implement improvements.
• Lead quarterly audits, report findings, and ensure timely closures.
• Prepare quality guidelines and instructions.
• Oversee raw material warehouse quality supporting manufacturing.
• Compile weekly, monthly, and quarterly logistics reports for customer review.

Requirements:

• Min Degree in Supply Chain or related study
• Min 3 years of quality experience in manufacturing setting, well wersed in methodologies such as CAPA, GDPMDS and Six Sigma

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Email: [email protected]

Recruitpedia Pte. Ltd.

EA License No. 19C9682

EA Reg. No. R2198636 (Oh Puey Xin)

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

Our client is a leading logistics company. They are looking for a Senior Quality Executive to assist their Quality team for the next phrase of their business. They are located at West of Singapore– easily accessible. The Senior Quality Executive is responsible for:

Duties

• Establish, update, and uphold the Quality and Environmental Management System (QEMS) in alignment with ISO 9001:2015, collaborating with stakeholders to create and revise relevant procedures.
• Track quality trends and performance metrics, ensuring continuous improvement within the organization.
• Manage internal and external ISO 9001:2015 certification processes, audits, and compliance to meet all required standards and objectives.
• Communicate quality assurance strategies and processes across the organization through quality programs, training, and awareness initiatives.
• Lead monthly quality review meetings, generate performance reports, and conduct site inspections to ensure compliance with quality standards.
• Participate in customer audits, lead investigations into quality issues, manage supplier onboarding, and address improvement areas based on non-conformities.

Requirements

• Min Diploma or Bachelor’s degree from an accredited institution in relevant Quality, Science or Engineering studies.
• Min 3-5 years of working experience in the quality function preferably in chemical, manufacturing, or logistics industry.

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Email Address: [email protected]

Recruitpedia Pte. Ltd.

EA License No: 19C9682

EA Reg. No. R23115141 (Tan Su Yee)

Our client is a Global Manufacturing MNC, one of the leading players in the Oil & Gas servicing sector. Due to their current expansion plan, they are looking for a Quality Engineer to join their team, in hopes of developing the current high performing team. They are located in the West.

Job Responsibilities

• Responsible for the creating and executing methods and procedures for the inspection, testing, and evaluation of the products and production equipment.
• Responsible for the designing and evaluating processes, mechanisms, and equipment used in inspection and testing.
• Responsible for quality assurance tests and statistical analyses to assess control levels and manage risks related to product quality
• Responsible for root cause analyses of incidents that necessitate corrective actions.
• Ensuring that corrective measures and deviations meet with the standards
• Ensuring that documentation is compliance with the Experienced Professional

Requirements

• Min Diploma in engineering or equivalent
• Min 3 years’ relevant working experience in Quality Management
• Certified in API Q1, Q2, ISO and other relevant auditor would be advantages.

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Recruitpedia Pte. Ltd.

EA License No. 19C9682

EA Reg. No. R23115553 (Lai Hor Yan)

The Company

Our client is a leading financial services assurance & advisory team that collaborates to build trust and solve important problems. Work with top-tier clients in the insurance sector and this is an excellent opportunity to get exposure in professional consulting firm for assurance services.

The Role

You will be working in teams to assist your Audit Seniors in audit support work for primarily the life insurance clients.

Your Profile

Ideally you shall equip with knowledge in Actuarial Science, Mathematics, Statistics or other related disciplines that possesses an analytical and quantitative component. A self-driven learner with the ability to quickly learn and apply new tools and techniques such as proprietary actuarial software and cash flow models. You should have an appreciation for structured methodical research, critical thinking and problem-solving skills with an understanding for the application of these skills in the business environment. A natural curiosity to identify, investigate and explain trends and patterns in data and the ability to analyse and break down complex concepts and technical findings into clear and simple language for communication to team members and clients.

You are expected to have working knowledge of Microsoft Office (Excel, Word), including VBA programming. Knowledge of any of the following will be an added advantage:

1. Programming (e.g. VBA, C++, Java, Python)
2. An analytical software (e.g. R, SAS)

Key Responsibilities:

• Develop and implement the overall testing strategy for new projects and existing applications.
• Design test plans, test cases, and test scripts based on requirements and specifications.
• Oversee the execution of manual and automated testing to ensure that all aspects of the application are thoroughly tested.
• Collaborate with development teams, business analysts to troubleshoot and resolve defects in a timely manner.
• Monitor testing progress and provide regular updates to stakeholders regarding test results, defects, risks, and issues.
• Ensure compliance with best practices in quality assurance and testing processes.
• Research and implement new tools and techniques to improve testing methodologies.
• Facilitate communication both within the testing team and with other departments, promoting a culture of quality.

Qualifications:

• Bachelor’s Degree in Computer Science, Information Technology, or a related field.
• 5 years of experience in software testing with 2 years in a managerial role.
• Knowledge of software development life cycle (SDLC) and testing methodologies.
• Experience with test management tools (e.g., JIRA, TestRail, etc) and automation tools (e.g., Tosca, Selenium, etc).
• Proven ability to lead and mentor a team while fostering a collaborative environment.
• Excellent analytical, problem-solving, and decision-making skills.
• Excellent communication skills in both written and verbal.

Job Description

• Provide regulatory advisory on MAS’ requirements.
• Perform gap analysis on new/revised MAS’ requirements.
• Maintain and review policies/procedures managed by Compliance team.
• Review marketing materials from a regulatory perspective.
• Review policies/procedures submitted by other teams.
• Design and perform compliance review.
• RNF
• Assign and maintain training records.
• Prepare periodic compliance reports to Head Office.
• Disseminate MAS’ update to Management and relevant teams.
• Participate or support regulatory or business projects involving Compliance team.
• Ad hoc tasks as assigned by Team Head.

Requirement

• Minimum 5 years of relevant regulatory compliance experience within a Banking environment
• Comprehensive knowledge of business standards, policies and procedures in a Banking environment (Private Banking is a plus).
• Well versed in Banking Act, Securities and Futures Act (SFA) and Financial Advisers Act (FAA) advisory
• Excellent communication and presentation skills, with the ability to interact with our Head Office colleagues in Taiwan

Meta is looking for an analytical thinker with experience in tech integrity compliance or policy, law, human rights, government, or risk management for our Content Policy team in APAC. The team’s mission is to create and communicate rules for how our products may be used by people on Meta’s family of applications. This person will be responsible for program management of regulatory compliance engagements, and regulatory compliance policy development and escalations with a focus on APAC.

Candidates must be able to work at pace to make difficult decisions under pressure, use critical thinking skills, have strong written communications, and demonstrate strong leadership and interpersonal skills to organize and build relationships with teams across the company. Candidates must be able to apply complex, evolving frameworks to new and developing regulatory compliance issues.

You will be responsible for managing escalations from regulatory compliance policies -- including by coordinating cross-functional responses to content decisions that take into consideration local regulatory compliance and international human rights obligations, product, operational considerations, and weigh up risk in order to provide effective policy advice to leadership.

You should be passionate about the services we provide and the people that we serve.

Responsibilities

• Develop and maintain the regulatory engagement program, focusing on crisis management and content regulation compliance. Collaborate with teams to integrate regulatory considerations, conduct risk assessments, design training programs, and appropriate success measurements.
• Help develop and refine principles and policies related to regulatory compliance with takedown requests. Special focus on compliance policies, including operations and product advocacy.
• Build relationships with and understand the perspectives of partners on internal teams, such as Public Policy, Human Rights Policy, Integrity Regulation Strategy & Policy, Core Policy, Operations, Communications, Trust & Safety and Legal.
• Act as an APAC escalation point of contact for regulatory escalations relating to freedom of expression, and manage internal communications for policy issues, including on-call rotations in time zone, with potential irregular hours.
• Produce and present internal communications for senior leadership to inform them of ongoing situations, and provide recommendations and decision support.
• Help articulate policy philosophy, launches, and changes to relevant parties, including management, operations, and other internal and external stakeholders.
• Work with Meta's Public Policy team, as well as external stakeholders, to monitor the global environment for issues that affect content policy.

Minimum Qualifications

• 6+ years experience working in integrity compliance or policy, law, human rights, government, or risk management with an emphasis on platforms and technology
• Cross-functional program or project management
• Experience with Internet/social media content issues
• Demonstrates analytical-thinking and problem-solving skills and project management experience
• Experience working cross-functionally and consensus-building
• Understanding of Meta's products and principles
• Ability to work irregular hours

Meta builds technologies that help people connect, find communities, and grow businesses. When Facebook launched in 2004, it changed the way people connect. Apps like Messenger, Instagram and WhatsApp further empowered billions around the world. Now, Meta is moving beyond 2D screens toward immersive experiences like augmented and virtual reality to help build the next evolution in social technology. People who choose to build their careers by building with us at Meta help shape a future that will take us beyond what digital connection makes possible today—beyond the constraints of screens, the limits of distance, and even the rules of physics.

Our client is a MNC in biotechnology industry. They are looking for a Trade Compliance Manager to join their Compliance Team for the next phase of their business. They are located in West.

Roles & Responsibilities

• Ensures compliance with regulatory authorities, including customs, export control, and tax agencies, while maintaining accurate documentation and procedures in alignment with relevant laws.
• Evaluates internal controls, designs processes, leads compliance audits, and manages corrective actions for the region. Pinpoints compliance deficiencies and suggests areas for improvement.
• Assists in creating and sustaining localized policies for import/export compliance, while ensuring company-wide awareness of regulatory requirements.
• Develops business processes that mitigate compliance risks, focusing on continuous improvement for increased efficiency and enhanced customer service.
• Tracks and reports key performance indicators (KPIs) and compliance metrics to senior leadership, while managing daily import and export compliance reports for the region.
• Establishes the overall budget, operational plans, and priorities for the assigned compliance functions.
• Manages regional compliance projects, including defining scope, budget, scheduling, and addressing project risks for both import and export activities.

Requirements

• Bachelor's degree and above
• Posses Customs broker license is a bonus
• Minimum 10 years of experience in trade compliance with 5 years of management experience
• Worked in medical devices or related industry

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Email Address: [email protected]

Recruitpedia Pte. Ltd.

EA License No: 19C9682

EA Personnel No: R2198636 (Oh Puey Xin)