Roles & Responsibilities

The RAQA Manager is responsible for overseeing regulatory compliance and quality affair functions within the organization. The RAQA Manager will work closely with the Head of RAQA and cross- functionally with teams including R&D, Product Development and Operations teams to ensure regulatory requirements and regulatory strategies are effectively implemented and quality systems are maintained and improved.

Key Responsibilities:

(a) Prepare good quality technical documentation.

(b) Manage regulatory submissions for pre-market product registration, renewals, and amendments to ensure timely market entry and compliance.

(c) Stay up to date on evolving regulations and guidelines and provide guidance to internal teams on regulatory landscape.

(d) Monitor post- market surveillance and timely reporting to regulatory authorities.

(e) Prepare and support internal audits, regulatory inspections and audits by notified body, regulatory agencies, partners, and addressing any findings or non- compliance issues that arise.

(f) Support supplier management and audits.

(g) Manage and maintain the effectiveness of Quality Management System (ISO 13485).

(h) Develop, implement and maintain SOPs and quality processes.

(i) Provide training to employees on regulatory and quality requirements.

(j) Responsible for database, processes and systems within RAQA.

Qualifications and Competency

(a) At least Bachelor’s degree in Life Sciences, Biomedical Engineering or a related field.

(b) At least 5 years of professional experience in regulatory affairs and quality affairs in medical device industry.

(c) In-depth knowledge of global regulatory frameworks (US FDA, EU MDR, TGA, SG HSA etc)

(d) Strong knowledge and understanding of ISO 13485, GMP, regulatory and quality standards

(e) Excellent project management, organizational and problem solving skills

(f) Strong attention to details with the ability to manage multiple priorities and deadlines.

(g) Excellent written and verbal communication skills

(h) Proficient in Microsoft Office

(i) Background in medical device manufacturing would be an added advantage.

Main duties and responsibilities :

1. Incoming QA(IQA) and Outgoing QA (OQA) Inspection
2. Quality Wall (QW) buy off
3. Weekly process audit
4. Non Conformance Material Report (NCMR)

Experience and knowledge :

1. Min "O” level with 3 years of related experiences in a manufacturing environment.
2. Knowledge of Microsoft (words, excel and ppt) is a must.
3. Knowledge of Stamping, Plating, Molding and Connector Assembly is an added essential.

Skill Required :

1. Good knowledge on measurement methodology and equipment (profile projector, TM scope, OGP smart scope).
2. Exposure in Process and QMS Audit.
3. Knowledge of Quality tools such as SPC and 7 QC tools.
4. Good interpretation of product drawing, specification and Inspection Plan.

Job Requirement :

1. Able to work independently
2. Able to work rotation shift

This is a Quality Inspector (QI) role to implement and carry out quality check to achieve high construction and workmanship quality in the delivery stage, to the satisfaction & expectation of our customers on apartment unit quality and in-line with our company vision of providing quality homes.

Responsibilities:

• IImplement and carry out the Standard Operation Procedure (SOP) for Construction Quality so that the work can achieve high construction and workmanship quality in the delivery stage.
• Ensure readiness for Temporary Occupation (TOP), that the work progress by contractor are inspected and recorded, so as to deliver quality homes to customers.
• Carry out Independent Quality Mark (QM) check of all units, monitor defects rectification after Temporary Occupation and during Defects liability Period (DLP).
• Co-ordinate with Customer Service Department (CSD) on the CDL in-house quality inspection.
• Ensure unit defects are rectified in a timely manner and within the time frame allowed or specified.
• On site implementation of our CDL 5-Star Environment, Health & Safety Policy and ensuring Contractor achieves the highest standard during every CDL 5-Star Quarterly Site Inspections

Requirements

• Diploma/ Degree in electrical/ mechanical, civil engineering or engineering disciplines
• At least 8-10 years’ experience in the construction industry especially on quality inspection and delivery
• Good written and verbal communication skills
• Excellent customer service skills with the ability to handle challenging customers effectively
• Meticulous with an eye for details

City Developments Limited (CDL) is committed to fostering an inclusive culture that respects the diversity of its employees and stakeholders. As a signatory of the Employers Pledge for Fair Employment with TAFEP since 2008, CDL’s recruitment process adheres to strict guidelines on non-discrimination and fairness, regardless of gender, ethnicity, religion, or age.

About Us:
Tecson Engineering is a leading electrical engineering company specializing in projects for the SMRT and public transportation sector. We pride ourselves on delivering high-quality, safe, and reliable solutions for our clients, ensuring the efficient operation of Singapore’s rail network.

Position Overview:
We are seeking a meticulous and experienced QA/QC Engineer to join our team. The successful candidate will oversee and manage quality assurance and quality control processes for our projects, with a particular focus on SMRT works and train-related projects. This role ensures that all engineering and construction activities comply with regulatory standards, client requirements, and Tecson Engineering’s quality policies.

Key Responsibilities:

• Quality Assurance:Develop, implement, and maintain QA/QC plans, policies, and procedures for SMRT projects.
  Ensure that project activities comply with relevant codes, standards, and client requirements.
  Conduct regular audits and inspections to monitor adherence to quality standards.
  
• Quality Control:Perform quality checks on materials, equipment, and installations to ensure compliance with specifications.
  Oversee testing and inspection of electrical systems and components.
  Identify and address non-conformance issues and implement corrective actions.
  
• Documentation and Reporting:Prepare and maintain QA/QC documentation, including inspection reports, test results, and compliance certificates.
  Generate regular quality performance reports for internal and client review.
  
• Collaboration:Work closely with project managers, engineers, and site supervisors to ensure quality expectations are met.
  Liaise with clients, consultants, and regulatory authorities regarding quality-related matters.
  
• Continuous Improvement:Recommend and implement improvements to QA/QC processes and practices.
  Conduct training sessions for team members on quality standards and procedures.
  

Requirements:

• Diploma or Bachelor’s Degree in Electrical Engineering or a related field.
• At least 2–3 years of QA/QC experience, preferably in rail or infrastructure projects.
• Strong knowledge of SMRT standards, local regulations, and safety guidelines.
• Familiarity with ISO 9001 quality management systems.
• Proficient in using quality management tools and software.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Certification in quality control or assurance (e.g., CQE, CQA) is an advantage.

Application Details:
Interested candidates are invited to submit their resume, along with a cover letter, detailing their relevant experience and qualifications to [email protected]

Join us in shaping the future of Singapore’s transportation infrastructure while maintaining the highest standards of quality and excellence!

Job Description:

1. Performing general inspection of parts and products at the Incoming/In-Process/Outgoing gate.
2. Generate Standard QA/QC inspection report.
3. Administrative tasks.
4. Logistics support.

Competence Requirements

• Preferred Secondary, NTC certification holder from related CNC/Fabrication industry.
• Preferably with 2 years of related work experience in manufacturing environment for non-technical trained staff.
• Able to read part drawing, usage of measuring equipment are added advantage.
• Computer competency.

Job Description:

• Assist Product Owner, Business Analyst to craft out user story acceptance criteria.
• Analyze and decompose complicated software systems, and design a holistic test strategy
• Research emerging technologies and develop test automation framework.
• Develop test suites of test scenarios and test cases.
• Perform time-boxed exploratory testing.
• Maintain regression test suite in QA nightly build.
• Actively refine the smoke test suite in the Development CI environment.
• Lead system integration testing with other systems.
• Manage user acceptance testing.
• Manage defect life cycle, test artifacts, and repository.
• Drive continuous improvement in agile testing practices and tools.
• Improve software quality using XP practices such as code review and unit testing.
• Understand the IT management policy, quality management policy and security guidelines to ensure the development processes, procedures and system are designed to comply.
• with these policies and guidelines.

Job Requirements:

• Bachelor’s degree in computer science, Software Engineering, or a related field (Advanced degrees are a plus).
• Minimum of 5 years of professional experience in Software Quality Assurance.
• Proven experience with automation testing, particularly using Cypress for E2E testing.
• Hands-on experience with performance testing tools like Gatling and Autocannon.
• Experience with contract testing frameworks such as Pact.js.
• Proficiency in JavaScript (TypeScript) and familiarity with Go.
• Solid understanding of frontend and backend technologies, including ReactJS, ExpressJS, and Gin-gonic.
• Experience with AWS services, Docker, and Kubernetes.
• Familiarity with CI/CD pipelines using GitLab and ArgoCD.
• Knowledge of relational databases (MySQL, PostgreSQL) and caching solutionsn(Redis)
• Understanding of REST API, GraphQL API, JWT authentication, and Elasticsearch.
• Experience with logging and monitoring tools like Splunk or OpenSearch.

Who We Are Looking For

We are looking for a Senior Quality Engineer who always strives to find innovative ways to improve product quality. Be part of a cross-functional Agile team of UX/UI designers, mobile and web developers, the product owner and business analysts, for a large-scale national strategic project in the education vertical. The team values quality, automation and user experience of the software we deliver.

Responsibilities:

• Champion and drive product quality and QE practices in an agile development environment
• Collaborate with multiple internal and external stakeholders to ensure that the product is built right
• Validate product features as per acceptance criteria
• Design, develop and maintain the testing environment, testing framework, test plan, regression test suites and test cases in accordance with changing requirements
• Uncover and fi x blind spots and edge cases in test cases
• Perform various tests such as Manual/Automated/Functional/Exploratory testing/Cross-Platform/Performance Testing for the various platforms (iOS, Android, Web)
• Conduct system integration tests with external systems and generate test reports
• Collaborate with development team to establish Continuous Integration and Delivery Pipeline

Requirements:

• Minimum 5 years of experience in quality engineering or relevant roles
• Strong foundation in test methodologies, good analytical skills, attention to detail and problem-solving abilities
• Experience in automated testing tools/frameworks (e.g. Cucumber, Selenium, Appium, Robot Framework)
• Knowledge in Behavior-Driven Development
• Experience in Non-Functional Testing such as security testing, as well as performance and load testing
• Good team player with good communication skills
• Good understanding of mobile (iOS and Android - React Native) and web technologies (e.g. React.js, Node.js) with the respective debugging tools
• Strong understanding of Unit Testing using JavaScript Framework (e.g. Jest, Mocha, Jasmine)
• Initiative to go the extra mile such as by exploring and creating tools to improve testing processes
• Additional certification in Software Quality Assurance is a plus

Roles and Responsibilities

• Develop and establish quality assurance deliverables and testing framework, including estimate testing scope and time needed based on user requirements, create and maintain test specifications in accordance with changing requirements, throughout development;

• Create and maintain automated test framework using tools such as Cucumber/Selenium to support continuous development and testing, including prepare test environment, create and maintain functional testing scripts in accordance with changing requirements;

• Conduct manual functional / exploratory testing to compliment automated testing, including browser testing and system integration tests with other modules;

• Conduct impact analysis of defect fixes discovered during manual or automated tests

• Validate stories using acceptance criteria, raising defects as needed and work with development team to improve the expected behaviours and test cases;

• Conduct performance and load tests if needed, validate the output and expected outcomes and feedback on improvement required;

• Conduct application performance and security testing if needed, to ensure we have a robust and secured system in place;

• Work with Business Analyst on UAT data preparation and support;

• Work collaboratively with the rest of the technical and business team, including understanding the business/user requirements to facilitate testing, participate in desk-checks to do early validation and verify completeness of story, as well as participate in showcases to demonstrate tested stories;

• Conduct system integration tests with external parties when necessary, validate the output and expected outcome e.g. data to and from external parties’ systems and feedback on improvement requirement;

• Work with DevOps team to establish process for deployment and maintaining CI/CD pipeline

Knowledge and Skills

• Tertiary education in relevant fields is preferred

• Experience in programming in Java / Python / NodeJs is preferred

• Hands-on experience with software testing including automated functional testing tools such as Cucumber, Selenium, Maven, Capybara is preferred.

• Experience doing automation testing in Agile development process will be an added advantage

• Have SQL scripting skills

• Hands-on experience in one or more of the followings is preferred:

o Application exploratory testing and regression test automation

o Application performance testing

o Application security testing

• Have relevant knowledge of software QA methodologies, tools, and processes

• Hands-on experience with performance testing tools such as JMeter, Gatling will be an added advantage

• Certified Software Testing Professional and/or Certified Software Quality Analyst will be an added advantage.

• Strong analytical and problem-solving skills

• Good presentation and listening skills

• Good writing skills

• Good communication and interpersonal skills

• Team player

• Meticulous attention to details

• Able to multi-task, take initiative and work independently with multiple stakeholders

Key Responsibilities :

• Prepare production campaign start-up, batch review, and review of cleaning records and activities.
• Manage and coordinate Change Control, Event (Deviation and Incident), Out-of-specification (OOS), and resolution.
• Maintain, improve, establish and update appropriate quality management systems to meet customers’ and authorities’ requirements.
• Assist to promote Quality culture for Bulletin, training, and organize promotion activities.
• Assist in quality discussion with respective departments to improve the quality system.
• Assist to plan, prepare and facilitate customers’ and regulatory authorities’ audits and follow-up action.
• Carry out Internal audits of all departments and supplier audits.
• Assist and improve qualification activities and quality risk management.
• Qualification of supplier and external contractor.
• Any other QA department job assigned by the Head of Quality Assurance.

Requirements :

• Degree in Chemical related field
• Proficient with Microsoft Office (Words, Excel)
• Strong oral and written communication in English
• Ability to work as a team in department.
• Good communication and collaboration skills to work with cross-functional teams.
• Working experience in Quality related field is preferred.

The purpose of this job is to assist the Company with the quality assurance activities on an ongoing basis. The role entails a variety of responsibilities, such as:

• Perform incoming material (e.g. cement, sand, etc), in-process and outgoing materials(UHPC Quality Mix) inspection activities according to the QAQC procedures and plans to ensure compliance with ISO and in-house standards.
• Operate and maintain QAQC laboratory equipment properties (e.g., TGA, BET, PSA, SEM, XRD, sieve analysis) to ensure optimal performance for analysing material, manage the safe storage of hazardous materials, and assist with periodic quality audits.
• Preparation of sampling list for weekly production and maintain the consumables inventory item at laboratory.
• Collect samples for incoming raw material quality checks.
• Manage retention samples, including proper labelling and organized storage.
• Maintain laboratory premises and equipment in accordance with the Company’s standards.
• File & maintain product inspection records.
• Perform 5S and laboratory housekeeping.
• Support the company’s research and development initiatives.
• Execute any additional duties or ad hoc tasks as assigned.
• Strictly adhere to safety standards in all activities to ensure a safe working environment for all.

Requirements

• Degree with at least 3 years of working experience in Quality System (preferably in Healthcare, Bio/Pharma, Health Services, biotechnology/biotherapies related industry)
• Good communication skills
• Team player with good coordination
• Meticulous, analytical and systematic
• Candidates with more experience will be considered for a Assistant Manager role

Descriptions

• Maintenance of organization’s quality management system in compliance to:

- regulatory requirements; MOH Healthcare Services Act and other regulatory relevant to the company’s services and products

- accreditation and certification standards; AABB (Association for the Advancement of Blood & Biotherapies), FACT (Foundation for the Accreditation of Cellular Therapy), GDP-MDS SS 620 (Good Distribution Practice for Medical Devices) and other standards when required for the company’s services/products

• Ensure requirements for AABB, FACT as well as MOH license guidelines are implemented and maintained
• Follow up and assist in deviations/ non-conformances (CAPA) for root cause analysis, rectification and process improvement
• Performance of Internal Audits and record checking and support External Audit to ensure compliance with regulatory and accreditation standards.
• Manage the Document Control system for the organization and ensure staff complies with the use of controlled and approved documents.
• Support supplier/ vendor qualification and audits
• Support change control activities
• Responsible for maintaining Quality Systems in the company.
• Responsible for monitoring and reviewing quality indicators and quality control reports across departments.

Job Description:

• Lead and guide sub-contractor to achieve quality workmanship
• Handle paperworks , defects issuance and reporting
• Conduct defects investigation and identification

Job Requirement:

• Minimum 4 years in CONQUAS
• Possess at least 2 good industry practices certificates
• Microsoft office knowledge
• Able to communicate with client and consultant

We are seeking a dedicated professional to champion quality assurance and testing practices, driving impactful change and ensuring the delivery of robust, user-centric solutions.

What to Expect:

• Define and maintain QA and Testing processes, including Test Management, Defects Management and Code Quality
• Coach and mentor IT Business Analysts and end users on QA and testing processes, fostering a culture of quality and excellence within IT teams.
• Work with selected projects, championing product quality and software testing practices in agile/waterfall project delivery.

How to Succeed:

• Degree in software engineering, computer engineering, electrical engineering, or related discipline.
• Minimum 5 years of experience in establishing test strategies for systems in agile development environments.
• Profound knowledge of various test types, levels, techniques, methodologies, and test automation, with a strong understanding of test-driven development and continuous integration/delivery principles.
• Hands-on test automation experience and the ability to integrate test automation into the Continuous Integration chain.
• Experience in QA Management for the system delivery and Certification in Testing and Software Quality Assurance will be a bonus.
• Organized, methodical, and meticulous in planning, management, and execution, with a strong focus on attention to detail and problem-solving.
• A team player who is self-motivated, proactive, and customer-oriented, with excellent communication and presentation skills.

Job Responsibilities

• Oversee and provide guidance to QC Inspection Team to ensure implementation of all inspection-related activities according to standards, including proper disposition and handling of non-conforming material/product.

- Pre-inspection of designated goods (at warehouse).

- Sampling and QC inspection of incoming materials (pre-shipment samples, raw materials, bulk, semi-finished and finished products, packaging materials) and out-going products.

- In-process inspection to ensure that quality, hygiene, and safety standards are met.

• Identify and investigate OOS (out-of-specification) or NC (non-conformance) cases, analyse the root causes, and monitor closely the resolution and correction status.
• Investigate product feedbacks, analyse quality-related problems, and recommend problem resolution.
• Handle product stability tests.
• Work with relevant parties (e.g. external provider and product owner) to establish specifications and quality attributes of raw material, packaging and product, confirm appropriate test method for each QC parameter, and document evidence.
• Contribute for establishing and improving relevant QC SOP and inspection/testing-related work instructions (in compliance with GMP and ISO requirements).
• Ensure proper QC documentation including Master Specifications, QC Records (including electronic logs), QC Test Reports, Lab Test Reports, Non-Conformance Reports, COA etc.
• Ensure cleaning and environmental monitoring programmes for the site are done accordingly.
• Manage retention room for retention, reference and post-inspection samples, and sample retention system.

Requirements

• Degree in Science or Engineering (preferably in Cosmetic Science, Chemistry, Pharmacy, Nutrition or relevant field).
• Preferably 1-3 years of experience in the quality control of cosmetics, pharmaceuticals, dietary supplement, food, or skincare/medical device.
• Experience in a GMP environment or knowledge of GMP an important plus.
• Knowledge of relevant product standards, quality control and test methods.
• Stringent compliance to procedures, guidelines, standards, and regulations.
• Self-starter, good at working well independently with initiatives.
• Meticulous & detail oriented.
• Analytical & problem-solving skills.
• Time management skills (scheduling, prioritising) to meet deadlines.

• 5 years Gray box QA
• Proven experience black box testing Client-Server products with a focus on Server/API testing
• Demonstrated ability to write automation - we currently use Python
• Experience testing RESTful APIs
• Proficiency in an object-oriented language like C#, Java, JavaScript, Perl, Ruby, or Swift
• Experience traversing Unix directory structures; use basic Unix commands to scrape log files
• Experience scrapping customer logs and web searches to design tests cases as end user would use it
• Acquaintance with continuous integration/deployment
• Familiarity with static code analysis tools
• Experience with basic database queries

Quality Assurance Inspectors examine products to ensure that they meet customer requirements and do not contain defects. Their job duties may include in-process inspection, in-coming inspection and/or out-going inspection.

A strong understanding of the industry

A successful Quality Inspector candidate will have various prerequisite skills and qualifications that typically include:

● Basic computer skills

● Documentation skills

● Written and verbal communication skills

● Attention to detail

● Ensure products meet customer expectations and demand

● An understanding of industry safety standards

● Ability to work well with others

● Perform regular quality assessments on all incoming materials from vendors and outgoing products for shipping

● Ability to analyse the quality and performance of a product

● Resolve quality-related issues in a timely manner.

● Measure product dimensions, examine functionality and compare the final product to the specifications.

● Able to make lot judgement

● Reject all products and materials that fail to meet quality expectations.

● Reporting skills

Requirements:

One to two years’ quality inspector experience Good math and technical skills.

Strong understanding of quality control standards and testing techniques. Knowledge of ISO 9001:2015 quality management systems is desired

Full Time

Location: Jurong

DUTIES AND RESPONSIBILITIES

1. Develop, implement and maintain quality management systems based on ISO standards.

2. Oversee the day-to-day quality control operations, ensuring compliance with established standards and procedures.

3. Providing guidance, training, and support to ensure consistent quality outcomes to quality control inspectors and technicians

4. Conduct regular audits and inspections to identify areas for improvement, non-conformities, and opportunities for enhancing quality processes.

5. Collaborate with production, engineering, and other departments to establish and enforce quality standards at all stages of the product lifecycle.

6. Enhance the development and execution of quality control plans, including sampling techniques, testing methodologies, and documentation procedures.

7. Manage the documentation of quality control activities, including inspection reports, test results, and corrective action plans.

8. Monitor and analyse quality metrics to track performance and identify trends, presenting findings to management and suggesting improvement strategies.

9. Stay up-to-date with the latest developments in ISO and OCO certifications, as well as industry best practices, and incorporate them into the quality management system.

10. Co-ordinate ISO audits by external certification bodies, ensuring all necessary documentation is in place and readily accessible.

Qualifications and experience:

· Bachelor's degree in a relevant field (Quality Management, Material Engineering, Manufacturing, etc.); advanced degree or certifications are a plus.

· Minimum of 3 years of experience in quality control, with a focus on ISO certifications.

· Strong understanding of ISO 9001 Standards, with the ability to interpret and implement their requirements effectively.

· Knowledge on Component FAI / PPAP / PSW from supplier are a plus

· Must be able to write and communicate in Mandarin and English as the position requires liaison and communication with China counterparts on equipment and material matters

· Proven experience in managing quality control teams, driving continuous improvement initiatives, and fostering a culture of quality excellence.

· Proficiency in quality control methodologies, statistical analysis, and root cause analysis techniques.

· Excellent communication skills, both written and verbal, with the ability to present complex technical information to diverse audiences.

· Detail-oriented mindset with exceptional organizational and problem-solving abilities.

· Familiarity with quality management software and tools.

· Strong leadership skills and the ability to collaborate effectively across departments.

Personal Qualities:

· Proactive, driven and resilient

· Able to work independently and as part of cross-cultural team

· Meticulous, accurate and attention to detail

Responsibilities

· To be responsible for Quality Assurance matters

· To provide accurate course information, including funding terms and conditions to sales team, learners and corporate clients

· To administer learner satisfaction surveys

Qualifications

· Degree in any major

·Excellent command of written and spoken English

· Pleasant disposition with strong communications skills

· Experionce in training industry or quality assurance is an added advantage

Responsibilities

• Environmental Quality Audit, that comprises of the following inspection units:
• Entrance and lobby, lift cars, planter boxes and containers, porches, pavement, aprons, sidewalks, external game courts, carpark, driveway, hard standing, loading and unloading bay, field, gardens, side tables, bin centre / bin chute.
• 50% of the following inspection units: classrooms, lecture halls, auditoriums, laboratories, offices, staff rooms, special rooms, rooftop, common staircase / landings / steps / common areas, toilets, external compound and handrails.
• During each Environmental Quality Audit, representatives shall be present to validate that all documentations submissions are in order.
• To follow-up of Environmental Quality Audit findings, gaps identified and recommendations till close out.
• To ensure consistent remarks, comments and assessment standard for all sites during the Environmental Quality Audit in the Environmental Quality Audit report.
• To use the electronic cleaning audit system, device and forms

Requirements

The Environmental Quality Auditor(s) shall possess the following competency and experience:

• Possess WSQ Advanced Certificate in Environmental Cleaning/Services for cleaning supervisor or possess a relevant WSQ Qualification or equivalent in cleaning supervision; and
• Possess valid Environmental Control Coordinator (“ECC”) license.
• Preferably 3 years in cleaning supervision or cleaning auditor; and
• Preferably 1 year as certified ECC practitioner.

Description:

• Review and analyse requirements, specifications, and technical design documents to provide timely and constructive feedback.
• Develop detailed, comprehensive, and well-structured test plans and test cases that adhere to industry standards.
• Effectively estimate, prioritize, plan, and coordinate testing activities to ensure comprehensive test coverage.
• Design, develop, and execute automated testing scripts utilizing reliable automated testing tools.
• Identify, document, and meticulously track defects, ensuring prompt resolution and thorough regression testing.
• Monitor the debugging process and track quality assurance metrics, including defect densities and open defect counts, to maintain high quality standards.
• Stay informed about emerging testing tools and methodologies to enhance testing effectiveness.
• Collaborate closely with development and project management teams to facilitate smooth SIT and UAT processes.

Job Requirement:

• Bachelor's degree in Computer Science, Engineering, or related field.
• Experience in software quality assurance is essential, demonstrating a strong understanding of QA methodologies, tools, and processes.
• The ability to develop clear, concise, and comprehensive test plans and test cases is also critical.
• Familiarity with Agile and Scrum development methodologies is highly regarded.

PM Singapore is currently looking to expand the CQV capabilities. This role will be supporting one of our many clients in the field of commissioning, qualification and validation work within the Life Sciences space.

Your day to day role would involve the following activities:

• Planning, Performance, and Coordination of Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubator etc), Clean Utilities Validation and cleaning validation in accordance with internal procedures and industry standards.
• The qualification includes, FAT, SAT, IQ, OQ, PQ of any additional modifications of existing manufacturing process equipment, package units (e.g. Ultrafiltration Unit, Chromatography Columns, autoclave, FIT testers), commercial off the shelves (COTS) analytical instruments, freezers,
• Create, review and approve equipment qualification and analytical instruments lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
• Can lead investigation revolving around discrepancies identified during qualification activities.

We would like to hear from candidates who have:

• Min 10 years of relevant experience in validation activities (including the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents)
• Leading daily validation meetings with cross functional teams in resolving validation issues.
• Experience in equipment qualification including analytical instrumentation and manufacturing equipment.
• Work experience in Pharmaceutical or BioPharma industries
• Hands on validation execution experience
• Able to execute activities in cGMP environment, including cleanrooms or technical areas.

Objectives of the position:

This role is for the validation of Customer technical requirements by means of inspection of In-coming goods and release lots in SAP with defined usage decisions. Testing of ISIR samples (type test) for product approval process (power, control & data cable) with compliance to company standards and verify compliance to the international cable standards e.g. EN / IEC requirements. Understanding of each testing standards and be able to communicate the requirements to respective parties including suppliers. Establish test specification to be followed by suppliers. To be able to operate all laboratory equipment in the process of cable type testing. Keep track of product approvals and Company's approved suppliers’ performance monitoring to ensure continuous product compliance to the intended specification. Corrective and preventive action process with supplier with CAR logging and follow-up for effective closure of complaints and issues related to product quality.

Knowledge in product testing and certification will be an added advantage.

Key Responsibilities:

1. Validate product quality conformance by conducting In-coming inspection and type testing for cable & accessories, include updating into SAP.

2. To be able to operate Laboratory test equipment for cable testing and accessories inspection

3. Understand international cable testing standards and inspection requirements with compliance to internal ISO procedures. Prepare test specification with detailed inspection requirement to be followed by the supplier.

4. Prepare and issue Customer test reports, certificates & COC

5. Track supplier quality by means of in-coming inspection or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined.

6. To generate supplier CAR and track for corrective action and effective closure of CARs by liaising with the supplier.

7. Liaising with relevant departments including suppliers to effectively close the CAR issued for Customer complaints or CAR’s which arise from internal findings (Z2 & Z8).

8. Maintain inspection records in SAP, determine skip lot and setup inspection requirements in SAP.

9. Assist Customer’s Technical enquiries e.g. Customer letter, RoHS, REACH & CE

10. Understand and comply with relevant ISO procedures, work instructions and corporate directives

11. Assist in other day to day activities related to QA department as assigned by superior.

12. Contribute to achieving company, department and personal KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

Skills & Qualification:

▪ Min. Diploma or Degree in Engineering (Electronics / Electrical) or equivalent

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification.

▪ Knowledge in ISO 9001:2015 QMS standard will be added advantage.

▪ To be able to operate lab equipment e.g. calliper, visual scope, resistance checker, High voltage tester etc.

▪ Prior experience in SAP system and knowledge of cable product testing is an added advantage

▪ Good written and communication skills

▪ Good customer handling skills and able to communicate to all levels in the organization

▪ Proficient in Microsoft Words and Excel

▪ Addresses present issues immediately and independently

▪ Possess self-confident and willing to share opinions and expertise in discussions

▪ Anticipate potential problems and takes action to avoid crisis

▪ Provide support to colleague in the Department and work as a team to achieve Department goals and targets

Mon to Fri 8.30am - 5.30pm

The Position

• The In-Market Quality, AP(SG/ID/VN/HK) Lead reports to AP In-Market Quality Lead.
• The incumbent is a leader of a team of 2-3 quality professionals responsible for In-Market Quality activities and maintains the affiliates within the cluster of countries in scope, in a state of GDP (and where applicable, GMP) compliance.
• The incumbent provides overall leadership and direction, coaching and training to the local In-Market Quality team; ensures that appropriate Quality Systems are established, implemented and maintained in each market in scope, and appropriate oversight is in place to ensure that local regulatory requirements are compliant and can be supported in a simple, cost effective manner, while working within the bounds of the global Quality Management System.
• The incumbent liaise with Global Quality, External Manufacturing Quality, the Quality Units of the manufacturing network, Regulatory Affairs / Pharmacovigilance and Supply Chain to support the commercial activities while maintaining Quality and Compliance.

Responsibilities:

• Responsible for the strategy, leadership, management and budgetary controls of a multi-cultural team of Quality professionals.
• Holds Employee Development Plan discussions and is responsible for executing the performance management process.
• Contributes to the development of the AP IMQ budget and tracks and controls expenses as needed to meet AP IMQ budget.
• Exhibits our company Leadership Behaviors and provides a leadership example for the team.
• Works strategically and in collaboration with other functions to continuously improve our company`s effectiveness and efficiency in quality management and quality systems supporting AP IMQ function.
• Ensure alignment of Indonesia, Singapore, Hong Kong and Vietnam market with applicable global GDP/GMP regulations, global quality systems and with agency expectations.
• Establish and maintain strong partnerships with key global/regional colleagues and teams that impact Quality and Compliance.
• Ensure deployment and implementation of new / revised QMS policies, standards and global SOPs.
• Establish performance management processes to monitor compliance and continuous quality improvements.
• Provide leadership and oversight for Significant Investigations, Fact Findings, HA notifications and Market Actions.
• Drive the development, implementation and realization of Permanent Inspection Readiness in collaboration with key stakeholders.

Required Education, Experience and Skills:

• Bachelor or Masters Degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent)
• Solid knowledge of global cGDPs/GMPs relevant to Marketing Authorizatin Holders and countries in scope
• Strong compliance mindset, excellent project management and organizations skills
• Excellent problem-solving skills, based on science, facts, data and understanding of regulatory requirements in complex and evolving environments; must be able to apply sound risk management principles
• Ability to be decisive and influence management with demonstrated leadership skills to drive change
• Ability to work collaboratively in team settings, across functions, and within matrix organisations to achieve objectives
• Strong commitment to diversity and employee development
• Strong demonstrated interpersonal, communication, collaborative and leadership skills in dealing with a broad variety of cultures
• Demonstrated ability to create simplicity out of complex environments and challenges Minimum

Preferred Education, Experience and Skills:

• Minimum of 5 years' experience in the pharmaceutical industry, with solid compliance experience.
• Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GDP and regulatory requirements.

Job Summary

Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative.

Role and Responsibilities

Quality Systems

1. Supports overall maintenance of quality systems

2. Monitor and reports on the quality performance for Asia Operations such as product quality performance, supplier performance and gaps for continuous improvement to the management team

3. Maintains the Master control and ISO document control system

4. Maintains customer related documents such as Quality Agreement, PPAP

5. Part of the Global Quality Team, to design and implementation of global policies and systems

Quality Policies

6. Ensures effective implementation of all company quality policies

7. Implements ISO and other recognized standards

8. Implements and monitors statistical techniques such as R&R’s to identify opportunities for improvement.

9. Sets, communicates, and implements quality objectives in line with business goals

10. Manage supplier and customer programs (CCAR, ICAR and SCARs) to ensure that complaints are handled effectively and timely.

11. Support and work with different stakeholders on reporting, monitoring and resolution on customer complaints.

12. Support and work with Supply Chain and Operation on supplier quality issues.

Auditing

13. Leads ISO quality standards implementation as Management Representative.

14. Conducts and leads quality audits to specific quality standards.

15. Leads customer related audits

16. Conducts supplier audits

17. Conducts internal audit investigations for product quality and process issues

18. Responsible for ensuring timely resolution to audit findings

Training

19. Provides training for all employees on basic quality and statistical concepts

20. Provides training to appropriate personnel for updates and changes to quality policy

21. Attends relevant external training sessions/courses and shares learning internally

Job Requirements:

• Degree or equivalent experience in a field of study such as chemistry, business, accounting, engineering, etc.

• Certificate in Quality Engineering is preferred.

• Position requires 3-6 years of quality management experience.

• Good experience into customer & supplier audit and able to conduct training

• ISO 13845 experience will be added advantage.

• Demonstrates introductory understanding and ability and with guidance, applies competency in typical situations.

• Able to design quality systems to meet customer expectations and internal needs. New approaches and continuous improvement must be ongoing

• Good interpersonal skills to be able to communicate and collaborate with all stakeholders and deal with situation proactively

• Junior with 1-2 experience in related field can also apply

• Occasionally overseas travel and weekly conference call is required for the role

• This position required to communicate closely with vendors in China.

Mon to Fri 8.30am - 5.30pm

Main scopes

• Quality Control and Assurance
• Documentation works
• Coordination with Contractors and Subcontractors
• Assisting Project Manager Planning project schedule

Requirements

• Education: Degree or Diploma in relevant job educations
• Experience: 1–3 years of relevant working experience. (Fresh graduations are welcome)
• Skills: Proficiency in computer software and paperworks