Job Description:

• Perform inspections on raw materials, intermediates and finished products by conduct sensory evaluation, carry out physical, analytical tests to ensure compliance with specifications and standards.
• Perform basic checks, calibration and maintenance of test equipment to ensure that test results are accurate.
• Assist and support in non-conformance and investigations of customers’ complaint samples or rejected items (Internal & External).
• Issue various documents (TDS, COA) internally (e.g. inter-department, affiliates) or externally (e.g by customers).
• Responsible for data entry, clerical and admin support.
• Maintain housekeeping of QC laboratory to ensure a clean and safe working environment.
• Assist and support in the implementation of continuous improvements in QA/QC functions.
• Carry out ad-hoc duties as assigned, when and where necessary.

Job Requirements:

• Minimum Diploma or Degree in Chemistry, Food Science and Technology, Analytical Chemistry or equivalent

Interested candidates do attach your resume to [email protected]

Attn: Angela Celeste Poh Li Ying (R2095367)

Recruit Express Pte Ltd (99C4599)

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.

• Well Established Company
• Basic $3000 - $3500 + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working day: Monday to Friday
• Working hours: 8.30am to 6.30pm

Job Responsibilities:

• Lead and supervise a team of QC inspectors overseeing daily QC inspections activities in compliance with established standards
• Provide training, coaching and mentoring to enhance the skills and performance of team members
• Prepare and maintain work schedule for the department to ensure optimize resource for overall efficiency
• Work with cross-functional teams to implement continuous improvement, track status of non-conformities and CAPA effectiveness
• Responsible for review and approval of DHR. Ensure quality records and samples are retained complying with good writing practice GDP requirements
• Implement quality documentation changes, such as QC procedures, process workflows, work instructions, etc. Guide the team to follow through the change
• Review and submit validation or verification measurement reports
• Perform daily process audit to meet quality operational requirements
• Assist in customer complaint analysis, investigation of quality issues and corresponding improvement measures
• Authorize the release (COC) of products, COA review and approval
• Monitor and report KPI of QC team job performance, production quality trends, quality control charts, etc.

Job Requirements:

• Possess minimum professional certification / Diploma / Degree in relevant subject area
• Working knowledge on ISO13485:2016 and quality assurance / quality control of medical devices is an added advantage
• Familiar with use of various quality control tools and test equipment

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

Need to know Zeiss CMM Program

Need to Know Zeiss CMM Operation

Have Quality Assuarnce & Quality Control Knowledge

Know incoming / In-process / External provider parts insepection

Know prepare of quality documentation and maintenance documents like daliy Monitoring Data and Monthly Data performance

Will preapare of documentation for customer audit and ISO audit

- 1 year renewable contract

- Up to 3,000 + PB

- Monday to Friday: 9am – 6.30pm

- Novena

Responsibilities:

• Deliver Quality Assurance objectives by conducting regular call reviews and highlight any potential risk to management.
• Review 15 of closed sales calls per day for General Insurance Team.
• Backup for Auto Insurance for Call Review purposes.
• Promptly report any calls detected with potential quality issues (e.g. misrepresentation, fraudulent) to Management.
• Prepare, track and send Quality Assurance related reports to UOB management and team. (NMD, Service Quality Monthly, Penalty Points Table)
• Keep track on all the status of Quality Assurance Cases from beginning to end process and provide update to management on a timely manner.
• Weekly meeting with management to discuss on discrepancies and solutions for further improvements.
• Other ad-hoc duties as assigned by supervisor

Period:

• 1 Year Renewable Contract

Location:

• Novena

Working Hours:

• Monday – Friday (9.00am – 6.30pm)

Salary:

• Up to 3,000 + PB

Requirements:

• Good to have BCP and PGI Certificates.
• Preferably have quality assurance experience and insurance products knowledge.
• Meticulous and responsible team player.
• Proficient in Microsoft Office.
• Able to multi-task.
• Fast Learner and willing to learn on multiple Insurance Products.

Interested applicants, kindly email your detailed resume (MS Word format is preferred):

[email protected] (Reg No: R1549023)

Please ensure that applications sent through email are no bigger than 1Mb.

We thank all applicants for your interest but regret to inform that only shortlisted candidates would be notified.

Success Resource Centre Pte Ltd (EA License Number: 04C3201)
160 Robinson Road, #13-07/08/09 SBF Center, Singapore 068914

T: 6337 3183 | W: www.successhrc.com.sg

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.

RESPONSIBILITIES

• Define and implement QA strategies, test plans, and test cases for web applications.
• Lead and mentor a team of QA engineers, fostering collaboration with cross-functional teams.
• Oversee all testing phases, including functional, integration, regression, performance, and security.
• Implement automation frameworks and optimize testing tools for continuous testing.
• Manage defect tracking, root cause analysis, and resolution to ensure seamless delivery.
• Ensure compliance with security, accessibility, and regulatory standards for web platforms.

• Bachelor's degree in computer science or equivalent.
• Minimum 5 years' experience of working experience in software testing and 2 years in leadership role
• Proficiency with QA tools (e.g., Selenium, JIRA, Postman) and automation frameworks (e.g., Katalon Studio, pCloudy).
• Familiarity with Agile and Scrum methodologies, along with scripting or programming languages (e.g., Python, JavaScript).
• Experience with performance testing tools (e.g., JMeter, LoadRunner) and end-to-end QA for complex web applications.
• Strong leadership, problem-solving, and communication skills

Job Description

• Industry/ Organization Type: Education
• Position Title: Quality Assurance Executive
• Working Location: Seletar
• Working Hours: 5 Days, Mon – Fri (9am – 6pm)
• Salary Package: Basic Salary (Up to $5,000) + AWS
• Duration: Permanent

Key Responsibilities

• Support the Manager in performing audits to ensure adherence to standards, including those under the Private Education Act, Private Education Regulations, EduTrust Certification Scheme, and Enhanced Registration Framework.
• Evaluate audit data to pinpoint performance discrepancies, observe trends, and assess process efficiency for ongoing enhancement.
• Work alongside departments to grasp relevant frameworks, organizational policies, and procedures, and suggest modifications.
• Discover opportunities for refining audit and/ or assessment processes.
• Other tasks as necessary.

APPLY NOW!!!

• Proficient in audit management, data analysis, quality assurance, and internal controls.
• Experience in Quality Assurance within a Private Education Institution (PEI) is an added advantage
• Familiarity with the Private Education Act, Enhanced Registration Framework, EduTrust Certification Scheme, and related standards is preferred.
• Excellent problem-solving, communication, and interpersonal abilities.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to [email protected]. Please indicate #71571 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Adelin Chong | EA Reg No.: R1875641

Job Scope

• Responsible to review and approve master batch records and subsequent batch records
• Review and approve cleaning records and procedures and ensure compliance with set
• Review and approve GMP documentation Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Review and approve deviations according to the site procedures
• Handle product complaints.
• Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
• Coordinate with cross-functional team to prepare Annual Product Reviews, discuss trends and atypical observations and recommend improvement actions.
• Conduct internal and external audits
• Maintain inspection readiness and support inspections from regulatory agencies and customers.
• Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
• Support the maintenance of validated stated of GMP systems and processes.
• Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner

Requirements

• Min Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.
• Minimum 3 relevant years of experience in QA/QC and GMP Compliance
• Familiar with manufacturing operations applications; six sigma and lean principles and process improvement tools.
• Thorough knowledge of GMP compliance regulations, ICH Q7a Guidelines, Good Documentation Practices and other applicable regulations.
• Proven track record of continuous improvement in quality operations or manufacturing.

All qualified applicants, please send in your resume to: [email protected]

Alex Goh Hock Leong (R1763413)

Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599

Job Description

• Industry/ Organization Type: Education
• Position Title: Quality Assurance Executive
• Working Location: Seletar
• Working Hours: 5 Days, Mon – Fri (9am – 6pm)
• Salary Package: Basic Salary (Up to $5,000) + AWS
• Duration: Permanent

Key Responsibilities

• Support the Manager in performing audits to ensure adherence to standards, including those under the Private Education Act, Private Education Regulations, EduTrust Certification Scheme, and Enhanced Registration Framework.
• Evaluate audit data to pinpoint performance discrepancies, observe trends, and assess process efficiency for ongoing enhancement.
• Work alongside departments to grasp relevant frameworks, organizational policies, and procedures, and suggest modifications.
• Discover opportunities for refining audit and/ or assessment processes.
• Other tasks as necessary.

APPLY NOW!!!

• Proficient in audit management, data analysis, quality assurance, and internal controls.
• Experience in Quality Assurance within a Private Education Institution (PEI) is an added advantage
• Familiarity with the Private Education Act, Enhanced Registration Framework, EduTrust Certification Scheme, and related standards is preferred.
• Excellent problem-solving, communication, and interpersonal abilities.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to [email protected]. Please indicate #71571 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Adelin Chong | EA Reg No.: R1875641

Our client is a global leader in the pharmaceutical industry, dedicated to improving health and well-being through innovative medicines and healthcare solutions.

They seek a Regional QA Specialist to lead regional internal and external audits for their external/contract manufacturers and suppliers, ensuring compliance with regulatory standards and upholding high-quality pharmaceutical, medical devices guidelines and requirements.

Key Points:

• New headcount with growing, reputable pharma MNC
• 5-day work in CDB area with hybrid work arrangements, near MRT
• Overseas travelling opportunities with attractive salary and perks

Responsibilities:

Uphold quality standards and activities of regional external/contract manufacturing organisations, ensure adherence to relevant international regulations, guidelines and industry practises alongside company compliance requirements.

• Perform internal and external audits (supplier or EMO/CMO) audits and assessments to evaluate compliance with quality standards and contractual requirements.
• Monitor EMO/supplier qualification, assessment and performance evaluation processes.
• Develop update and maintain Quality and Technical Agreements with current GxP guidelines.
• Maintain and update internal audit program.
• Plan audit schedules and facilitate process for audit findings to be resolves and all change implementations to be fulfilled with defined targeted datelines in compliance to GMP and company SOPs.
• Proper records and documentation in accordance with regulatory guidelines such as GMP document, site master files, quality manual and agreements.
• Establish and maintain QMS to ensure content compliance to all regulations and company practises, overseeing Validation QA.
• Provide training and guidance to quality staff on quality documentation, including system – Veeva (QMS), compliance training system etc.
• Collaborate with quality team and carry out assigned quality audit activities for continuous improvement throughout the organization.

Requirements:

• Bachelor's degree in a Chemistry, Pharmacy, or a related discipline; preferred Science or Engineering.
• Minimum of 5 years of experience in pharmaceutical or medical device industry, including 3 years in relevant quality compliance and audit roles.
• Experienced in auditing, especially with experience managing overseas EMO/CMO/third party manufacturing experience is highly preferred.
• Strong GMP, Computer system validation, deviation management, CAPA, change control and documentation management in pharmaceutical / medical device MNC environment.
• Demonstrate pro-activeness to drive results even amidst crises and ambiguity, thriving in fast-paced and dynamic environments.
• Successful proven track records of implementing continuous improvement projects with regional teams to enhance overall business operations.
• Possess strong cross-functional collaboration skills and adept stakeholder management capabilities. Skilled in building and maintaining relationships at all levels, both internally and externally.

NOTE: Position title may change based on candidate's experience, qualifications, and company structure at time of offer. This is to ensure alignment with candidate and organizational needs.

The selection process involves careful consideration, and only shortlisted candidates will be contacted. We extend our gratitude to all applicants for their interest and effort in applying.

Principal Consultant: Amber Chen | Registration Number: R22108633 | EA License Number: R1110404

• Drive quality culture and promote GMP compliance behaviors to the site.
• Ensure site compliance to Quality Standards (QS) and ICH guidelines.
• Provide QA oversight to the site GMP operations to ensure products produced in compliance with the Quality Standards (PQS).
• Collaborate with cross functional teams to improve quality systems.
• Understand regulatory expectations and support site inspection readiness.
• Work with supply chain and drug product sites to ensure timely delivery of quality products.
• Work with GCMC to file products and address regulatory queries in an accurate and timely manner.
• Require working on rotating shift.

For interested candidates, please send your updated resume:

Email: [email protected]

Whatsapp: 96503173

Telegram: @jesswongie

Jessie Wong Yuan Si

R2197171

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

Job Description

To perform inspection by using CMM & other measuring equipments

To ensure parts are according to customer's requirements

Job Requirements

Higher NITEC level in technical engineering or GCE 'O' level

Minimum 1 year related working experiences

Able to operate CMM machine independently is an advantage

Able to commit overtime

Good team player

Independent

• 5 days work week
• Location: North

Job Scope:

• Take charge of our Integrated Management System, ensuring processes are documented, owned, and regularly improved.
• Lead internal audits by preparing schedules, conducting audits, reporting findings, and implementing corrective actions.
• Investigate non-conformances, pinpoint root causes, and implement effective solutions to enhance operational quality.
• Oversee compliance with QHSE standards, ensuring alignment with industry and customer requirements.
• Manage document control systems, keeping records accurate, up-to-date, and aligned with regulatory needs.
• Conduct internal training to ensure the team stays ahead in aviation-related standards and practices.
• Collaborate with cross-functional teams to monitor and report quality metrics, driving data-driven decisions.
• Lead quality investigations, identify improvement opportunities, and escalate key findings to management.

Job Requirement:

• A Diploma/Degree in Engineering, preferably in Quality Engineering.
• At least 2 years of hands-on Quality Assurance experience in the aviation industry.
• Proficiency with ISO standards (ISO 9001, ISO 14001, TS 16949) and statistical tools.
• Strong analytical mindset with excellent problem-solving and communication skills.
• Internal/Lead Auditor certification (preferred) and a passion for knowledge-sharing (Train-the-Trainer qualification is a bonus).

To Apply, kindly click on the "APPLY NOW" button

We regret that only shortlisted candidates will be notified.

Staffking Pte Ltd (20C0358) | Chong Kar Ming (John) (R21101412)

Job Description

• Industry/ Organization Type: Education
• Position Title: Quality Assurance Executive
• Working Location: Seletar
• Working Hours: 5 Days, Mon – Fri (9am – 6pm)
• Salary Package: Basic Salary (Up to $5,000) + AWS
• Duration: Permanent

Key Responsibilities

• Support the Manager in performing audits to ensure adherence to standards, including those under the Private Education Act, Private Education Regulations, EduTrust Certification Scheme, and Enhanced Registration Framework.
• Evaluate audit data to pinpoint performance discrepancies, observe trends, and assess process efficiency for ongoing enhancement.
• Work alongside departments to grasp relevant frameworks, organizational policies, and procedures, and suggest modifications.
• Discover opportunities for refining audit and/ or assessment processes.
• Other tasks as necessary.

APPLY NOW!!!

• Proficient in audit management, data analysis, quality assurance, and internal controls.
• Experience in Quality Assurance within a Private Education Institution (PEI) is an added advantage
• Familiarity with the Private Education Act, Enhanced Registration Framework, EduTrust Certification Scheme, and related standards is preferred.
• Excellent problem-solving, communication, and interpersonal abilities.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to [email protected]. Please indicate #71571 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Adelin Chong | EA Reg No.: R1875641

TikTok is the leading destination for short-form mobile video. At TikTok, our mission is to inspire creativity and bring joy. TikTok's global headquarters are in Los Angeles and Singapore, and its offices include New York, London, Dublin, Paris, Berlin, Dubai, Jakarta, Seoul, and Tokyo.

Why Join Us

Creation is the core of TikTok's purpose. Our platform is built to help imagination thrive. This is doubly true of the teams that make TikTok possible.

Together, we inspire creativity and bring joy - a mission we all believe in and aim towards achieving every day.

To us, every challenge, no matter how difficult, is an opportunity; to learn, to innovate, and to grow as one team. Status quo? Never. Courage? Always.

At TikTok, we create together and grow together. That's how we drive impact - for ourselves, our company, and the communities we serve.

Join us.

Team Intro

The TikTok Live QA team has been focusing on the high quality and the best user experience of TikTok Live products. Our team uses advanced autotesting tools and comprehensive quality assurance methods to continuously control the delivery of products. We are looking for passionate Quality Assurance engineers to join this fast growing industry.

Responsibilities:

1. Responsible for the quality assurance of ByteDance's live-streaming products;

2. Deeply involved in the product development process, coordinate with various roles to continuously deliver products with high quality;

3. Improve product quality and efficiency through technical means such as tool platform development, automated testing and performance testing;

4. Prospective technology research and application, applying appropriate technology to improve business quality.

Qualifications

Minimum Qualifications:

1. BS degree in Computer Science or equivalent majors, with at least one year of native or backend quality assurance experience;

2. Good computer foundation, master at least one of the programming languages: Python,Java,Go,PHP;

3. Abilities to design and execute complete testing plans for complex projects;

Preferred Qualifications:

1. Master Degree in Computer Science or equivalent majors

2. Good logical thinking and team communication skills;

3. Having systematic work experience in automated testing, performance testing, and quality system construction is preferred.

TikTok is committed to creating an inclusive space where employees are valued for their skills, experiences, and unique perspectives. Our platform connects people from across the globe and so does our workplace. At TikTok, our mission is to inspire creativity and bring joy. To achieve that goal, we are committed to celebrating our diverse voices and to creating an environment that reflects the many communities we reach. We are passionate about this and hope you are too.

Key Highlights

• Contract Duration: 6 months
• Nearest MRT: Stadium
• Salary: $3,500 - $5,000 per month
• Working Arrangement: Monday – Friday (Office Hours)

Responsibilities

• Review and improve the ISO (International Organization for Standardization) documentation for preparation of internal and external audits. Validate that all documents are updated and recorded as per requirements
• Validate documents compliance and document findings
• Oversee the review and digitalisation of ISO forms
• Conduct review of improvements on Workplace Safety & Health (WSH) incidents and recommend improvements
• Review risk assessment plans to comply with the WSH Act
• Prepare PowerPoint on sharing and learning on safety for stakeholders
• Collate data and conduct trend analysis on incident and summons/warning letters etc
• Introduce, review, and revise quality standards and specifications for safe operations, focusing on regulatory requirements for fire safety, water rides safety, and water quality
• Validate that the venues, programmes and major events comply with regulatory standards and safety policies
• Organise training needs analysis and recommend safety trainings for staff and stakeholders
• Coordinate Occupational Health & Safety (OHS) Committee and Senior Management meetings
• Implement work improvement teams in the organization
• Coordinate safety initiatives and campaigns
• Manage data collection and analysis for safety initiatives and quality assurance projects

Requirements

• Diploma and/or Degree in any field.
• Experience in safety management, sports, project management and/or event organization will be advantageous.
• Registered MOM Workplace Safety and Health Officer, SCDF Fire Safety Manager, or BCA Ride Manager, with strong expertise in local safety regulations, risk management, and investigation processes will be preferred.
• Able to communicate in a clear and confident manner, written and verbal.
• Strong team player.

Interested candidates please click "Apply Now". We regret to inform you that only shortlisted candidates will be contacted for further discussion.

Wong Xue Ying

BGC Group Pte Ltd

EA License No: 05C3053

Registration No. R22108799

Responsibilities

Quality Assurance:

• Overall implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and 21 CFR 820 standards.
• Ensure all departments carry out due processes and documentation required to ensure conformance to the QMS, including design & development, production and software.
• Conduct internal audits and lead external audit preparations.
• Conduct Management Review, onboarding training for new employees, and company-wide refresher training
• Collaborate with cross-functional teams to address non-conformances, CAPAs, and continuous improvement initiatives.
• Participate in risk analysis and management activities to ensure compliance with ISO 14971.
• Support post-market surveillance and vigilance reporting activities.

Regulatory Affairs:

• Preparation, submission, and maintenance of regulatory documentation for market approvals in regions including Singapore, US, Malaysia, and Australia.
• Monitor and interpret regulatory updates and standards relevant to medical devices.
• Ensure labeling, packaging, and promotional materials comply with regulatory requirements.
• Collaborate with the R&D and manufacturing teams to ensure product compliance during development and production phases.
• Maintain accurate and organized records to support regulatory inspections and audits.

Minimum Skills and Requirements

• Bachelor’s degree in Engineering, Science, or a related field.
• Ability to work independently and cross-functionally with different teams
• Strong organizational and analytical skills.
• Effective communication and teamwork abilities.

Advantageous Skills

• Knowledge or experience with regulatory submissions to Malaysia MDA, Australia TGA, US FDA, and Singapore HSA.
• Familiarity with ISO 13485, ISO 14971, and other relevant standards.

Mon to Fri 8.30am - 5.30pm

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

Objectives of the position:

This role is for the Customer Quality Support for Company’s product distribution where Customer’s feedback & Product Quality requirements / issues are handled. The person will be responsible to handle Customers requirements such as complaints, test data & other technical information as requested. Customer complaints handling will also include the necessary communication with all the stake holders (Customer, Supplier, CS, PP, SVM, LOG). Knowledge in cable testing and specification requirements will be required to understand Customer complaints (technical & logistics).

Key Responsibilities:

1. Manage Customer complaint processes such as acknowledgement of the complaint, updating into SAP, keeping track of the complaint, closure of the complaint & summarizing for monthly reporting. Proper handling of customers’ needs by providing accurate and timely information on enquiries related to cable standards, test reports and handling of customer complaints.

2. Track supplier quality by means of in-coming inspection when required or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined. To generate supplier CAR and track for corrective action by liaising with the supplier.

3. Familiar with and comply to international cable testing standards and procedures. Contribute to achieving company & department KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

4. Liaising with relevant departments to effectively close the Customer complaints

5. Maintain records in SAP

6. Operate Laboratory test equipment when required

7. Assist Customer’s Technical enquiries e.g Product Test Report, RoHS, REACH, CE

8. Supplier claim processes and 8D report.

9. Prepare and issue Customer Test Certificates & COC

10. Assist in other day to day activities related to QA department as assigned by Superior.

Skills & Qualification:

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

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification. Training will be provided.

▪ Knowledge in ISO 9001 : 2015 QMS standard.

▪ Must be able to operate lab equipment (calliper, visual scope, resistance checker, High voltage tester).

▪ Prior experience in SAP system is required for this role. 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

Job Description

• Working with Process Engineer & Engineering team on QC requirement
• Documenting inspection criteria and quality plan
• Work with QA, Process and Product team on corrective action with quality issue
• Work with Process team on in-process audit and FQC audit

Job Requirements:

• Minimum Diploma in Manufacturing /Quality Engineering
• At least 1 year of relevant working experience in Electronics Product Manufacturing environment
• Control of Supplier Quality Assurance (SQA)
• Quality control of in-coming, in-process and out-going products
• Knowledge of ISO 9001, 14001, 13485 & 45001, FDA requirement
• Able to understand IPC requirement in PCB
• Assembly, quality requirement of plastic molding, die casting, extrusion, metal stamping and machining parts

*Please be notified that only shortlisted candidates will be notified*

By submtting your personal data and/or resume, you give consent to the collection, use, and disclosure of your personal data and/or resume by the company (or its agent) for the purpose of the processing and administration by the company relating to this job application.

EA Personnel Name: Chan Jun Wei

EA Personnel No: R1543992

EA License No: 21C0845

Job Scope

• Project management: analytical, raw material and microbiological method introduction and analytical equipment qualification
• Assist in regulatory filing and method launch
• Helping out in invalid results tracking, trending and investigation
• Conducting unexpected results investigation
• Control trend establishment and investigations
• Reference standard and reagent qualifications
• Conducting compendia review
• Assisting in audit preparation and involvement and other tasks as assigned.

Job Requirements

• A minimum experience of 3-5 years in Pharmaceutical, Biopharmaceutical or related manufacturing environment.
• Six Sigma Greenbelt training would be helpful.
• Demonstrated experience e.g. in the area of method validation, method transfer, method verification.
• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

For interested candidates, please send your updated resume:

The Career Conversion Programme (CCP) (Train-and-Place with Commitment to Hire) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand.

The training programme consists of 15 months of local attachment with GSK. Due to the nature of the programme, we can only consider Singapore Citizens and Singapore Permanent Residents. For more information, please visit Career Conversion Programmes (CCP) for Individuals.

Purpose:

• To manage QC equipment life cycle from qualification to decommissioning including calibration and maintenance plan follow up

Key Responsibilities:

• Technical responsibilities
• Manage new QC equipment qualification as per change control and validation processes (i.e. URS, System classification, Audit trail review assessment, DQ/IQ/OQ, PPC09)
• Be author of SOPs/ protocols/ reports/ training materials
• Manage decomissioning of QC equipment and follow disposal
• process
• Maintain our QC asset listing up to date Follow QC equipment routine lifecycle
• Coordination of calibration and maintenance plan with user and external vendor/TS team
• Coordination of equipment troubleshooting if occurence of failure/breakdow (i.e. Tag in/out equipment, Work order creation)
• Sample transfer, alarm management and cleaning for fridges, freezers and incubators
• Liaise with external vendor for service quotation, escort vendor during service and approve invoice timely
• Supports compliance activities:
• Performs regular Ll audits in QC
• Coordinates and supports all L2, L3 and L4 audits and the associated CAPAs
• Lead and manage continuous improvement projects Subject-matter-expert (SME)/ audit fronter for assigned topics
• Manage ad-hoc tasks
• Organization and Management Responsibilities
• Creates strong team morale and a culture of accountability and ownership
• Provides leadership, guidance and technical expertise/support to the juniors
• Ensures continuous improvements of the QC operations
• Ensures expenditures are within budget
• Decision Making
• Proposals & Recommendations
• Based on experience & knowledge of work
• Proposal of CAPA for any issues/ deviations/ exceptions/ risks
• Proposal of QC improvement projects and strategies
• Team training and development

Skills:

Professional

• For Specialist - University Degree in a relevant Science discipline with at least 2 years of working experience or Diploma with at least 5 years of working experience
• For Senior Specialist - University Degree in a relevant Science discipline with at least 4 years of working experience or Diploma with at least 8 years of working experience

Technical

• Competent technical skills in project management
• Computer system validation Knowledge of cGLP & cGMP

Business

• Effective report writing skills
• Planning and Organizing skills
• Good interpersonal and communication skills
• Effective team player
• Analytical skills with logical thinking Problem solving skills

Competencies:

• Effective report writing skills
• Planning and organization skills
• Able to work independently
• Team player
• Analytical skills with logical thinking
• Leadership skills (advantage)
  ​​

Where will I be based?

You will be based at one of our manufacturing site in Singapore near Tuas.

This position is responsible for conducting audit checks to ensure that products meet the established standards, This role also supports the achievement of Company quality target.

1. Confirm to quality standard and quality processes

• Inspect in-coming and outgoing products according to policies standard.
• Perform all product processes within section (eg, QC,SAO), Reworks, Repairs, Defective photo-taking

2. Contribute to continuous improvement

• Maintain Integrity accuracy and completeness of Supplier invoice data and QC data in system
• Establish standard operating procedures and conditions for handling storage and checklist of stock.

3. Perform other ad-hoc duties as assigned.

Requirements

• At least 1 year of experience in Gold quality control in retail jewellery preferred
• If no QC experience in retail jewellery then at least 1 year of experience in QC control in manufacturing
• At least Diploma in any discipline
• Basic understanding of production methods.
• Attention to detail
• Able to use basic MS Office.
• Good Communication and Interpersonal Skills
• Able to multi-task and quick learner

The Career Conversion Programme (CCP) (Train-and-Place with Commitment to Hire) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand.

The training programme consists of 15 months of local attachment with GSK. Due to the nature of the programme, we can only consider Singapore Citizens and Singapore Permanent Residents. For more information, please visit Career Conversion Programmes (CCP) for Individuals

Purpose:

• To perform testing and support related activities in QC Biological team

Key Responsibilities:

• Perform routine and adhoc/ non-routine testing in the following areas with good observation of GMP requirements:
• Biological testings for raw materials release (All QA controlled materials). Biological testings refer to biochemistry and/ or microbiological testings.
• Biological testings for intermediates and product
• Biological testings for utilities (city water, purified water, water of injection, compressed gases, etc)
• Biological testings required to support manufacturing process validations and confirmations
• Perform routine environmental sampling in controlled environmental areas
• Initiate and participate in laboratory investigation (OOS / deviations / atypical results / invalid results) and assist in timely closure of the investigation and CAPA
• Perform equipment calibration, maintenance and validation
• Participate in method transfer / verification / validation
• Participate in peer review for verification of task and data
• Assist in SOP writing
• Identify and report problems in QC to QC Superintendent in a timely manner
• Practice 6S and ensure good housekeeping of laboratory, work area and equipment
• Ensure good inventory of QC materials (purchased and prepared materials / glassware) to support testings; ensure no over surplus of inventory
• Ensure wastes are disposed appropriately and promptly
• Adheres to all safety and security policies and practices
• Assist the Senior Superintendent/Superintendent in the management and operations of the team; may be indirectly responsible for a team of associates:
• Scheduling day-to-day shopfloor activities and resources handling to ensure timely availability of test results
• Reviews test reports to ensure accuracy of test results in accordance with corporate, regulatory and external agency regulations.
• Provides training to the team.
• Provides guidance, support and technical expertise to the team.
• Involves in investigation and protocol writing (when required)
• Involves in SOP writing and updating
• Organization and Problem Solving:
• Creates strong team morale and a culture of accountability and ownership
• Recommends and coordinates appropriate corrective actions to quality problems in conjunction with other teams/ departments
• Presents in timely manner major issues to the management with strategies on their resolution.

Skills:

Professional

• For QC Associate, fresh graduate in NITEC/ Diploma in Microbiology, Biotechnology, Life Sciences, Chemistry, Biochemistry
• For Senior QC Associate, NITEC/Diploma in Microbiology, Biotechnology, Life Sciences, Chemistry, Biochemistry, with at least 2 years of working experiences or Fresh degree holder in Microbiology Biotechnology, Life Sciences, Chemistry, Biochemistry. Increased number of years of experiences are required for higher positions.
• For Lead QC Associate, NITEC/Diploma in Microbiology, Biotechnology, Life Sciences, Chemistry, Biochemistry, with at least 8 years of working experiences or Degree holder in Microbiology, Biotechnology, Life Sciences, Chemistry, Biochemistry with at least 4 years of working experiences.

Technical

• Competent technical skills in the following:
• Good laboratory knowledge and hands-on experience in chemistry testings o Laboratory equipment qualification
• (advantage)
• Knowledge of cGLP & cGMP (advantage)

Business

• Effective report writing skills
• Planning and Organizing skills
• Effective team player
• Analytical skills with logical thinking
• Good interpersonal skills
• Leadership skills (advantage)

Competencies:

• Good command of English
• Good knowledge on usage of computers

Where will I be based?

You will be based at one of our manufacturing site in Singapore near Tuas.

• Possess knowledge in GMP and halal certification processes
• Assist in GMP preparation for audit
• Assist QC manager in daily operations
• Testing of finished products against specifications and to notify for any out of specifications
• Maintenance of manufacturing facility as per GMP requirements
• Prepare products for testing from external laboratories
• Conduct instrument analysis and calibration of laboratory equipment and basic equipment maintenance
• Assist in generation of Certificate of Analysis
• Conduct incoming materials check

Requirements

• Minimum Diploma in Chemistry or relevant courses
• Minimum 2 years of experience
• Able to work independently with minimal supervision
• Able to write and communicate in English
• Knowledge in Excel and word
• Knowledge in SAP will be an added advantage