Total 11 Manager 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.

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

Prudential’s purpose is to be partners for every life and protectors for every future. Our purpose encourages everything we do by creating a culture in which diversity is celebrated and inclusion assured, for our people, customers, and partners. We provide a platform for our people to do their best work and make an impact to the business, and we support our people’s career ambitions. We pledge to make Prudential a place where you can Connect, Grow, and Succeed.

This role is responsible to deliver the right protection and group product solutions to targeted customer segments through our distribution channels (Agency, Bancassurance/Partnership, Group, Digital, etc) and also to ensure effective maintenance of the existing product shelf.

Job Description:

• Ideation and development of new product solutions that are market leading, meet customer needs and improve financial performance.
• Support the implementation of strategic initiative across PACS to drive the protection and group business
• Work with Actuarial Pricing in achieving a balance for all stakeholders, eg. Compensation, pricing, product benefits, time to market, etc
• Participate and support the Head of Department in engagement with distribution partners on product ideation and development
• Work with the delivery/implementation team and other stakeholders to ensure product launch is in accordance to the product plan and meets the objectives of the business case
• Work with marketing and distribution teams to provide education, support and communication tools to better target new customer and service existing customers.
• Tracks performance of products launched and collaborate with stakeholders to improve its performance and/or address any gaps
• Actively monitor the competitive environment and provide the relevant analysis and/or recommendation to support the distribution

Who we are looking for:

Competencies & Personal Traits

• Strong analytical skills and an ability to understand complex insurance product levers
• Good spoken, presentation skills and written communication as well as articulate interpersonal and negotiation skills
• Demonstrate influence and maturity for effective collaboration across departments
• Adaptable and can deal with change and ambiguity
• Dynamic individual who strives in fast moving environment

Working Experience

• Diploma / Degree with at least 8 years or more of experience with successful track records in the area of life product developments
• Ability to work in a team effectively while managing tight timelines and working in a fast-paced environment
• Independent and able to manage relationships with internal and external stakeholders

Education

• Degree in Actuarial/Marketing/Business Administration/Mathematics or related discipline

Language

• English

Prudential is an equal opportunity employer. We provide equality of opportunity of benefits for all who apply and who perform work for our organisation irrespective of sex, race, age, ethnic origin, educational, social and cultural background, marital status, pregnancy and maternity, religion or belief, disability or part-time / fixed-term work, or any other status protected by applicable law. We encourage the same standards from our recruitment and third-party suppliers taking into account the context of grade, job and location. We also allow for reasonable adjustments to support people with individual physical or mental health requirements.

Overview

The Job Holder will support in building improvement capabilities and culture in the NUHS Regional Health System Office (RHSO), including community partners such as GPs. The Job Holder will be involved in co-developing and conducting quality improvement training for RHSO staff and community partners, as well as facilitate and coach small to large scale improvement projects through the use of appropriate tools/methodologies.

Job Responsibilities

1. Deliver QI Training

• Develop training materials and resources (e.g. training guides and e-learning videos) on quality improvement
• Conduct and facilitate quality improvement training sessions/workshops for RHSO staff and partners
• Gather feedback on training sessions and use of appropriate improvement methodologies/tools
• Deliver training on lean management and human-centred tools to impart knowledge and skills to hospital staff.

1. Facilitation of improvement projects

• Facilitate and coach department/division and organisation-wide level improvement projects to improving quality and processes through the use of appropriate tools/methodologies
• Monitor the progress of improvement activities and guide teams to take appropriate actions
• Assist in interpreting data to measure the effectiveness of the improvement activities

1. Strategy & Culture Building

• Assist in development and implementation of Improvement framework and strategies
• Support initiatives or events that promote improvement and Innovation culture in RHSO
• Lead engagement with HODs to influence and identify areas of improvement in quality and safety

1. Any other tasks as assigned

Requirements

Qualification Required and Area of Discipline

Good degree in any discipline, preferably in Life Sciences, Business Administration, Industrial Design

Prior healthcare sector experience is preferred

Required Competencies and Capabilities (Skills, Experiences and Professional Licences)

• Proficient in quality improvement methodologies such as Lean, process/value-stream mapping, design thinking
• At least 1-2 years of experience in facilitating workshops and conducting trainings
• Confident in coaching and guiding fellow colleagues in Quality Improvement tools
• Certified Six Sigma Green/Black Belt will be an added advantage
• Able to engage stakeholders and work through doctors, nurses, allied health professionals, operations and administrative staff
• Able to work independently and as a team
• Ability to perform even under tight timelines
• Good analytical and organization skills
• Good writing and verbal communication skills
• Open to learning and trying new things. Able to grasp concepts easily and be able to think on the feet.
• Highly self-driven and self-motivated, positive attitude and perseverance to overcome obstacles

Primary Purpose

Reporting to the Senior Manager, Supply Chain SMO/COE, the Master Data Quality & Governance Manager plays a vital role in ensuring the accuracy and integrity of master data and will be responsible for overseeing and implementing data governance strategies, policies, practices, and processes across the Asia Pacific region. This role is also responsible for collaborating with APAC business stakeholders to understand their data needs and requirements and ensuring data quality standards, processes and procedures align with business objectives, and providing training and support to business stakeholders on data quality best practices.

Develop and Implement Data Governance Framework:

o Design and establish a comprehensive data governance framework across the Asia Pacific region.

o In partnership with Global Data Governance teams define data governance policies, procedures, and standards to ensure consistent and accurate data management practices.

o Collaborate with stakeholders to gain buy-in and support for the data governance initiatives.

Data Stewardship and Ownership:

o Establish data quality rules, monitor data compliance, and resolve data-related issues.

o Ensure data ownership and accountability by establishing data governance and execution roles and responsibilities.

o Drive continuous improvement by monitoring data governance performance and identifying opportunities for enhancement.

o Conduct regular data audits and assessments to identify gaps and recommend corrective actions.

o Collaborate with cross-functional teams, including IT, finance, operations, privacy and legal to ensure alignment and compliance with data governance initiatives.

o Engage with global stakeholders to share best practices, leverage synergies, and contribute to the overall data governance strategy.

Training and Awareness:

o Develop training programs and materials to educate employees on data governance policies, procedures, and best practices.

o Raise awareness of the importance of data governance and its impact on business operations and decision-making.

o Provide guidance and support to business units in implementing data governance practices effectively.

o Act as a subject matter expert, providing guidance and support to stakeholders on data governance-related matters.

Inherent Requirements

Formal Qualifications

Bachelor's in information management, computer science, business administration, or a related field.

Key Skills / Core Competencies

• Strategic thinking ability, as well as detailed analytical and problem-solving skills
• Strong communication and relationship building skills to collaborate cross functionally with internal partners and external customers.
• Comfort in managing relationships with senior leadership.
• Strong entrepreneurial, customer service orientation.
• Ability to effectively prioritize, execute tasks and manage deadlines in a high-pressure environment.
• Good written, oral, and interpersonal communication skills.
• An ability to work well in an ambiguous environment with minimum supervision.
• Strong professional presence and business acumen.
• Innovative, proactive, and flexible to change.
• Self-motivation and a strong sense of ownership and accountability
• Exposure to process improvement methodologies with Lean Six sigma Green or Black belt an advantage

Experience

• Proven experience in data governance, data management, or related roles, preferably within a multinational organization operating in the Asia Pacific region.
• In-depth knowledge of data governance frameworks, principles, and best practices.
• Strong understanding of data quality management, data privacy regulations, and data-related compliance requirements.
• Demonstrable experience leading process change
• Superior vendor management experience
• Demonstrable knowledge and experience in SAP, SFDC, M365, BI and data analysis tools.

Job Duties:

• Manage the process for QMS audits, to ensure compliance of the organization’s Integrated Management Systems wrt ISO9001/TS16949/ VDA 6.3, Customer specific requirements.
• Identify areas/ system gaps for improvement and implementation. Establish and drive QMS enhancement and integration roadmap/milestones.
• Work closely with Operations and key stakeholders to maintain consistent manufacturing, quality policies and compliance
• Responsible for maintaining/improving fab performance though SPC program.
• Investigate root causes and resolve key fab-related quality issues and effectiveness of corrective and preventive actions. Manage Non-Conformance cases with respect to on-time closure with the relevant customers/Business Lines.
• Responsible for Outgoing and Periodic review OQA performance to drive defect reductions
• Responsible for Document Centre Management & Library Services
• Management of change among diverse cultures in a fast paced environment
• Co-work with related functions to support the wafer fabrication process to drive process/system optimization and effectiveness

Job Qualifications:

• Degree in Chemical / Electrical Engineering / Physics / Chemistry or equivalent
• 8+ years in semiconductor industry preferred
• Knowledge of wafer fabrication process essential
• Strong in project management skills, facilitation, analytical skills and system thinking

Job Description & Responsibilities:

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Work with technical team to create quality document related to product design, development and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Develop and evaluate medical device regulatory intelligence and maximize opportunities to expedite the registration process within S.E.A region, China and USA. Activities include obtaining and maintaining domestic and regional market access for our innovative products.
• Provide appropriate inputs to assist in defining regulatory strategies and timelines for regulatory submissions for the total product lifecycle for medical devices.
• Compile technical, clinical and production protocols and documentations necessary for new products dossier submission to S.E.A. region, China and USA. regulatory submissions. Liaise with technical team (locally and internationally) on technical information required to prepare submission dossiers. Manage preparation (developing submission content, management of document legalization, and creation of any other documents required for submissions) and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution clearances in accordance with regulatory strategic plan.
• Overall responsible for ensuring that medical device files are set up in compliance to regulatory requirement.
• Monitor and communicate new and changing medical device law, guidance regulations in a timely manner. Reviews process change recommendation and assists in implementing new procedures and documentation.
• Ensure that regulatory records are controlled and maintained.
• Train internal and external stakeholders on regulatory data management processes and platforms, regulatory matters and product registration.

Job Requirements:

• Master or Bachelor of Science/Engineering with strong background in biomedical, computer or engineering sciences.
• Possess 3 years or more of working experience in quality assurance and regulatory affairs in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge of Health Sciences Authority requirement for IVD product submission.
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Experience with product registration submission and evaluation.
• Experience with maintaining internal regulatory database.
• Experience with Dossier Creation.
• Ability to develop and implement plans for regulatory submission.
• Awareness of applicable workplace environment, health and safety regulations.
• Ability to network and build strategic partnership with good problem solving skills and communication skills.
• Possess leadership and agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Job Summary:

• Industry: Healthcare
• Working location: Kent Ridge

Job Responsibilities:

• Leads quality improvement initiatives and spearheads innovation projects, identifying areas for enhancement and implementing best practices.
• Assists in managing the day-to-day operations of the department, ensuring high standards of patient care and staff performance
• Analyzes data and prepares reports on quality metrics and innovation outcomes.
• Conducts training on quality improvement, new technologies, and innovative care practices, including facilitating quality improvement workshops.
• Ensures compliance with healthcare regulations and organizational policies. Supports Nursing in compliance to audits’ standards.
• Participates in interdepartmental meetings and committees to represent the Nursing Departments’ quality and innovation interests.
• Supports the department in managing administrative support and coordination with external parties for innovative projects and research grants.
• Establishes and maintains relationships with funding agencies, potential partners, and other stakeholders in the healthcare innovation ecosystem.
• Facilitate, coordinate and support Nursing Leadership with the department's annual work plan.
• Consolidates, reviews, and analyses periodic and ad-hoc statistical and management reports
• Undertakes any other tasks assigned.

Job Requirements:

• Bachelor’s Degree in Business/Engineering/Industrial Design/Healthcare from a recognized institution.
• Possess knowledge of quality improvement methodologies and innovation processes in healthcare.
• Strong understanding of AI and robotics applications in healthcare, or willingness to learn.
• Proficient in Microsoft Office, in particular Word, Excel and PowerPoint.
• At least two years of experience in facilitating workshops and conducting training.
• Familiarity with data analysis and statistical tools
• Knowledge of lean management principles and Six Sigma methodologies.

By submitting any application or résumé to us, you will be deemed to have agreed and consented to us disclosing your personal information to prospective employers for their consideration.

We regret that only short-listed candidates will be notified.

Registration No: R24123448 / EA Licence No: 12C6253

Job Description & Responsibilities

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Ensure the overall document control system supports the QMS.
• Work with technical team to create quality document related to product design, development, and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Lead auditor for internal and external audits.
• Conduct management review, ensure QMS stays current and relevant.
• Lead in root cause analysis and CAPA.
• Analyze trends inquality performance.
• Drive improvement in the quality management system.

Job Qualifications

• At least a Master's degree in Science/Engineering or relevant related field.
• Possess at least 4 years of working experience in quality assurance in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development, and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Strong background in biomedical, computer or engineering sciences.
• Awareness of applicable workplace environment, health, and safety regulations.
• Possess creative skills and problem-solving skills.
• Adeptness in cultivating professional networks and build strategic partnerships.
• Good communication skills.
• Demonstrates strong leadership capabilities and an agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Job Description & Responsibilities

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Ensure the overall document control system supports the QMS.
• Work with technical team to create quality document related to product design, development, and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Lead auditor for internal and external audits.
• Conduct management review, ensure QMS stays current and relevant.
• Lead in root cause analysis and CAPA.
• Analyze trends inquality performance.
• Drive improvement in the quality management system.

Job Qualifications

• At least a Bachelor’s degree in Science/Engineering or relevant related field.
• Possess at least 4 years of working experience in quality assurance in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development, and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Strong background in biomedical, computer or engineering sciences.
• Awareness of applicable workplace environment, health, and safety regulations.
• Possess creative skills and problem-solving skills.
• Adeptness in cultivating professional networks and build strategic partnerships.
• Good communication skills.
• Demonstrates strong leadership capabilities and an agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

We are looking for a Quality Control Manager.

Job Description:

• Inspect in-coming and outgoing products according to policies standard.
• Manage inhouse and supplier’s quality (Lightings and Event Logistics Items)
• Establish standard operating procedures and conditions for handling storage and checklist of stock.
• Perform other ad-hoc duties as assigned.

Requirements

• Basic understanding of production methods for decoration lightings and Event logistics
• Attention to detail
• Good Communication and Interpersonal Skills
• Able to multi-task and quick learner