Regulatory Affairs and Quality Assurance Intern

We're seeking a detail-oriented and organized individual to support our Regulatory Affairs and Quality Assurance (RAQA) team.

We are looking for an intern who can begin in May/Jun 2025, and can commit for at least 4 months.

Key Responsibilities

- Maintain and update regulatory documentation and records for submissions

- Ensure regulatory databases are current and compliant with regulatory requirements

- Compile and maintain post-market vigilance documentation

- Assist in CAPA investigations for customer complaints, non-compliance, and audit findings

- Implement corrective actions as needed

- Maintain QMS documentation and records

- Provide support for ad-hoc tasks and projects

Ideal Candidate

- Open to uni undergrad students from all faculties

- Strong interest in regulatory affairs and quality assurance

- Ability to work in a detail-oriented and organized manner

If you're eager to learn and contribute to our RAQA team, we encourage you to apply!

Responsibilities

• Internal and external excursion management (MRB / Quality Claims)
• Customer data reporting
• Conduct Quality related training
• Support customer survey and audits
• Continuous improvement activities

Requirements

• Bachelor's degree in Engineering or Science.
• Strong systematic and analytical problem-solving abilities.
• Proactive attitude with the ability to handle multiple tasks simultaneously.
• Excellent communication skills and a collaborative team player.
• Understanding of system flow and databases; basic SQL knowledge is advantageous.
  

For Experienced Candidates:

• Proven experience with QA tools such as 8D, FMEA, fishbone diagrams, and AND.
• Solid working knowledge of Statistical Process Control (SPC) and auditing practices.

For Entry-Level Candidates:

• Willingness to learn and adapt to new QA tools and methodologies.
• Basic understanding of quality assurance principles and practices.
• Freshgraduate with part time working experience during Uni time (aside from internship) is a plus.

Responsibilities (include but are not limited to):

· Work with the Manufacturing department as a production area Quality Assurance representative

· Coordinate and facilitate Quality Assurance related production and production related activities

· Ensure timely issuance of production records, procedures and labels

· Ensure timely assessment and closure of discrepancies, Deviations and Change Controls

· Review batch-related documentation, and ensure resolution of issues to release product

· Communicate lot disposition pending issues to Management

· Ensure approval and timely delivery of Final Product

· Ensure that products are manufactured in compliance with regulatory and GMP guidelines

· Review and approve Manufacturing and Validation documents for Regulatory and Kite compliance

· Review and approve Manufacturing Production Records

· Compile and verify all batch related documents into a Final Product lot disposition package

· Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues

· Review and disposition disposable raw materials and components for GMP use

· Review equipment and facility technical and investigation reports

· Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies

· Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.

· Perform other duties as required

Requirements:

• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents
• No Experience Needed, Full training/ on the job guidance will be provided
• Able to start immediately

If you are interested in any of the positions, do kindly drop your most updated resume to [email protected] (Attn: QA Specialist)

Thank You.

Leon Leong De Cong
R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

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.

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

Job Responsibilities:

• Management of Quality Management Systems.
• Support and maintain relevant systems both internally and externally.
• Responsible for Documentation Control system and Audits.

Job Requirements:

• Good working experience.
• Precision manufacturing industry.
• Adequate understanding of Quality Management System.
• Team player with good initiative and proactive.
• Microsoft office.

Job Responsibilities:
- Maintains the Company Integrated Management System, ensuring all business processes are documented, have a designated owner and a plan for their maintenance, aligned to Survitec strategy and associated accreditation and/or regulatory frameworks.

- Perform internal audit procedure and schedule as per Department audit plans, to include the audit Scope, Objective and Criteria. Deliver the audit report including findings; agree on corrective actions with auditees and refer findings to the Manager.

- Investigate non-conformances using current and appropriate methods, systems, and procedures, taking action to solve immediate compliance issues.

- Identifies shortcomings in quality processes or outputs, identifies root cause and works with internal stakeholder to adjust processes or working practices to remove or mitigate any production quality issues; uses established change management programs to address issues and deliver sustained improvements.

- Attend aviation related training and create/refresh and update on internal company aviation training notes.
Conduct internal company training as per aviation requirements.

- Implements systems to ensure compliance with QHSE policies, group and Customer requirements; ensures audit, inspection and risk management are adhered to and embedded throughout the system.

- Document control system management, revision and updating.

- Defines and communicates the processes and schedule for audit, working with colleagues from the Quality function to ensure all supplier, operational, technical, health, safety and environmental audit activity is carried out as planned.

- Leads and participates in quality, non-conformance and customer complaint investigations.

- Provides written reports on audit and investigation findings, implements and monitors CAPA and improvement actions. Ensures findings are reported and escalated appropriately.

- Works with Survitec QHSE colleagues to develop tools and dashboards for the statistical analyses on which recommendations for improvement are based. Ensures outputs from QHSE reporting tools and dashboards are communicated to and understood by the business.

- Inform manager of audit findings and compliance issues, including capability gaps, workflow issues or matters requiring quality development or improvement.

- Any others tasks/projects as assigned by line manager from time to time.


Job Requirements:
- Degree/Diploma in Engineering (preferably Quality Engineering).

- At least 2 years of Quality Assurance experience in Aviation industry.

- Knowledge of ISO 9001, ISO 14001, and TS 16949.

- Proficiency in statistical tools and Microsoft Office.

- Strong analytical, problem-solving, and communication skills
Certified Internal/Lead Auditor (preferred).

- Train the trainer qualification will have added advantage.

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.

Job Description:

• Contribute to Life Science projects for Antaes Asia clients
• Ensure products manufactured meet approved company policies, processes and procedures
• Provide quality oversight of GMP manufacturing and support, including technical operations, engineering, QC Laboratory and supply chain activities
• Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/ line-clearance activities and administration of Quality Logs, e.g. QA Hold, QA tag out
• Release incoming material, process and product batches.
• Participate in investigations, arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing and product
• Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable polices
• Perform regular walk-thru of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times
• Participate and support new product introduction, operation excellence projects and other tasks as assigned by team
• Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Requirements:

• Bachelor’s Degree in Chemical Engineering, Biotechnology, Life Science or equivalent
• Minimum 2+ years of pharmaceutical, experience in Quality and/ or Compliance (GxP) environment
• Knowledge of quality/ compliance management as well as regulations and standard affecting APIs/ Biologics
• Ability to quickly know products and processes in order to assess quality issues
• Experience in SAP, Trackwise
• Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
• Excellent communication skills, both written and verbal, in English

Job Description

As a Quality and Compliance Specialist, you will play a pivotal role in ensuring that all products and operations within Project WATT meet regulatory requirements and quality standards. This role focuses on managing product certification, conducting regulatory audits, and ensuring that operational processes align with local and international laws. Collaborating with technical and operational teams, you will safeguard compliance while driving continuous improvement in quality management.

Responsibilities

• Product Quality Compliance:

1. Ensure that all products (hardware and software) comply with relevant regulations and industry standards, such as TR25 for EV charging systems in Singapore.
2. Maintain and update product certifications and manage regulatory audits and inspections.
3. Review testing results and performance reports to verify adherence to quality standards.

• Operational Compliance:

1. Oversee business operations to ensure alignment with legal and regulatory requirements, such as data privacy and environmental standards.
2. Develop, update, and optimize internal compliance policies and procedures to reflect current regulations.
3. Prepare and submit compliance reports, maintaining effective communication with regulatory authorities.

• Team Collaboration:

1. Work closely with technical teams, including Firmware Engineers and Integration Engineers, to validate the compliance of products and systems.
2. Provide compliance guidance and training to other teams to promote a culture of regulatory awareness.

• Risk Identification and Management:

1. Identify potential compliance risks and recommend actionable improvements to mitigate them.
2. Lead quality and compliance enhancement projects, ensuring continuous improvement in these areas.

Requirements

• A bachelor’s degree in Engineering, Quality Management, Law, or a related field, with at least 3 years of experience in product quality or compliance management. Equivalent professional experience will also be considered.
• Strong understanding of regulatory requirements for EV charging systems or IoT products, including certifications such as TR25.
• Experience managing audits and certification processes with regulatory bodies.
• Proven ability to collaborate effectively with cross-functional teams to ensure adherence to compliance and quality standards.
• Strong analytical and problem-solving skills with meticulous attention to detail in documentation and reporting.
• Knowledge of operational compliance standards, such as data privacy laws or environmental regulations, is a plus.

Reporting to:

Project Manager

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!

ABOUT THE JOB

The Quality Operations Specialist plays a critical role in overseeing the quality system within manufacturing and production areas. This includes monitoring, documenting, and addressing quality-related issues to ensure compliance with company standards and regulatory requirements. The role involves collaborating with various teams to uphold the highest quality standards for released batches.

Key Responsibilities:

• Ensure manufactured products adhere to company policies, processes, and procedures.
• Provide quality oversight for GMP manufacturing, including technical operations, engineering, QC labs, and supply chain activities.
• Review and approve incoming material inspections, batch records, manufacturing logs, and line-clearance activities.
• Manage the release of materials and product batches.
• Investigate non-compliance issues in materials, QC testing, manufacturing, warehousing, and products.
• Support change management processes to ensure compliance with policies.
• Conduct routine inspections of manufacturing, engineering, warehouse, and QC areas to maintain compliance.
• Contribute to new product introductions, operational excellence initiatives, and other management-assigned tasks.

ABOUT YOU

• Bachelor’s degree in Natural Sciences (Biology, Chemistry), Pharmacy, or Engineering.
• 2+ years of experience in a pharmaceutical or biopharmaceutical quality/compliance environment (GxP).
• Familiarity with quality regulations and standards affecting APIs/Biologics.
• Experience with SAP and Trackwise is a plus.
• Strong knowledge of GxP requirements and regulatory standards.
• Ability to quickly understand products and processes to address quality issues effectively.
• Commitment to maintaining high-quality standards with integrity and a strong work ethic.
• Excellent planning, scheduling, and communication skills.
• Strong interpersonal skills for effective collaboration.

WHAT WE OFFER

• An international community bringing together diverse perspectives and expertise.
• Opportunities for continuous professional development through our robust training programs.
• A vibrant workplace with frequent internal events fostering collaboration and innovation.
• Commitment to Corporate Social Responsibility through our sustainability initiatives.

Equal Opportunity

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Responsibilities:

• Validation quality review of lifecyle documents and protocols for Automation CSV qualification, EFU qualification, cleaning validation, laboratory equipment qualification, and IT systems qualification.
• Review and approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines timely
• Review and approve as needed, qualification/validation executed package validation exceptions, deviation, and investigations encountered during qualification/validation representing Quality
• Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities
• Participate in site Validation Maintenance Program
• Any other tasks as and when assigned by supervisor
• Support other technical changes and duties as require

About You:

• Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science
• At least 5 years qualification/validation experience
• Possess process automation experience will be the additional benefit to be considered
• Communicate well, self driven, motivated and able to work well with others
• Based in Tuas

Job Type: Contract

Contract length: 9 months

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

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 $5000 - $6500 + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working day: Monday to Friday
• Working hours: 8.30am to 5.30pm
• QMS | ISO 13485 | Medical Devices

Job Responsibilities:

• Conduct assessment and review on supplier qualification, performance and process capability
• Ensure supplier quality issues are deal with, analysed, improved and follow through
• Collect, handle and follow-up on customer feedback/complaints
• Support internal, external and customer audits
• Evaluation, verification and validation of new parts/samples
• Establish and maintain inspection criteria for incoming, in-process and final products
• Identify quality issues, NCR, CAPA handling and drive continuous improvement
• Authorize the release (COC) of products, COA review & approval
• Monthly data analysis on product quality and quality objective
• Review and approval on DHR
• Participate in new projects, commercial product quality management and control
• Drive change management and control
• Other ad hoc duties as assigned

Job Requirements:

• Possess minimum Diploma/Degree in relevant subject area with 2 years’ experience in medical device QA and/or RA
• ISO 13485:2016 certified internal auditor will be advantageous
• Familiar with quality control tools

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

• Well Established Medical Devices Manufacturing Company
• Basic $2200 - $3000 + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working hours: 12 Hours Shift

Job Responsibilities:

• Carry out inspection of incoming materials and finished products according to operational instructions to ensure that materials or products meet the requirements
• Ensure product identification is correct and stored in the correct location, maintenance of inspection equipment and daily monitoring of production environment
• Statistics on the quality status of incoming materials and processes and the quality of shipped products
• Report abnormalities to superior in timely manner and inform relevant departments and track the improvement status of non-conformities
• Assist in customer complaint analysis and take corresponding improvement measures
• Ensure records comply with good writing practice GDP requirements
• Assist the superior to complete other tasks

Job Requirements:

• At least 1 year of quality management experience and basic computer software
• Blueprint reading capabilities, and ability to use measuring devices like gauges, meters, calipers
• Documentation and reporting skills

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.

NG JYA YEE (R23119014)

EA Recruitment Pte Ltd

EA License No: 21C0492

• Well Established Medical Devices Manufacturing Company
• Basic $2200 - $3000 + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working hours: 12 Hours Shift

Job Responsibilities:

• Carry out inspection of incoming materials and finished products according to operational instructions to ensure that materials or products meet the requirements
• Ensure product identification is correct and stored in the correct location, maintenance of inspection equipment and daily monitoring of production environment
• Statistics on the quality status of incoming materials and processes and the quality of shipped products
• Report abnormalities to superior in timely manner and inform relevant departments and track the improvement status of non-conformities
• Assist in customer complaint analysis and take corresponding improvement measures
• Ensure records comply with good writing practice GDP requirements
• Assist the superior to complete other tasks

Job Requirements:

• At least 1 year of quality management experience and basic computer software
• Blueprint reading capabilities, and ability to use measuring devices like gauges, meters, calipers
• Documentation and reporting skills

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

Quality Operations Specialists must assist site management to oversee the quality system execution on the manufacturing and production areas at all times.

The personnel are required to observe, document, discuss, and report quality adverse events related to the manufacturing of the product and are responsible to ensure highest quality and compliance of released batches.

Responsibilities:

• Ensure that products manufactured meet approved company policies, processes and procedures.
• Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities.
• Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out.
• Release incoming material, process, and product batches.
• Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product.
• Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies.
• Perform regular walk-through of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times.
• Participate and support new product introduction, operation excellence projects and other tasks as assigned by management.

About You:

• Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Engineering, Pharmacy or other relevant courses.
• Prior knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics.
• Minimum of 3 years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.
• Experience in SAP, Trackwise are preferred.
• Ability to quickly know products and processes in order to assess quality issues.
• Committed to quality and maintain a high standard of work at all times.
• Demonstrates the highest levels of integrity and a strong work ethic.
• Good knowledge of GxP requirements and regulations.
• Good planning and scheduling skills.
• Good communication and interpersonal skills both verbal and written.

Contract Period: 12 months, subject to renewal based on performance.

Based in Tuas.

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

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

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

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

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

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

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

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

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

10. Other projects as assigned.

As an intern for the Assurance, your responsibilities include:

• Working as part of an audit team to complete, or assist in the completion of audit tasks which includes financial and statutory audits of companies
• Assist the team to perform analytical review of audit documents
• Assist the team with the preparation of supporting documents to support the opinion in the financial statements
• Assist the team with vouching of audit documents
• Assist the team to preform statutory reviews
• Assist the team to perform administrative works such as referencing, casting, indexing, etc.

Requirments:

• Training will be provided
• You must be a Singaporean or SPR, and able to commit for at least 3 months

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

What We Value:

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

Responsibilities

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

Requirements

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

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

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

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

NOTICE

We regret to inform that only shortlisted candidates will be notified. All applications will be treated with the strictest confidence.

By submitting any application or resume to us, you will be deemed to have read and agreed to the terms of our Privacy Policy, and consented to us collecting, using, retaining and disclosing your personal information to prospective employers for their consideration.

Consequences of Not Providing Personal Data for Transaction/Service/Application

Please be noted that should you not consent and provide use with the relevant personal data to fulfil the “Purposes” of collection, use and disclosure of your personal data by HerdHR, it may hinder our ability to continue to interact with you. We may not be able to make a decision on your recruitment and employment or comply with the law and therefore, we may not be able to make an offer of employment

You may refer and access our website for more information.

About Cynapse

Cynapse is an awarded AI Software Product company specializing in Enterprise-grade Vision AI in highly challenging environments. Our software platform is leveraging cutting-edge cloud/on-premises/edge platforms, advanced computer vision algos, advanced ML concepts & models and more.

The company is led by globally renowned experts who previously headed large groups at Microsoft and Intel. The company HQ is located in Singapore (One North Area) and operates in over 10 countries.

Cynapse is looking for a talented and highly motivated Project Management Officer (PMO)/Quality Assurance (QA) Intern to join our team that delivers challenging, enterprise-scale Video Content Analytics solutions to global customers. You will conform to high standards of project planning and management, working in a cutting-edge, dynamic and professionally challenging environment.

Successful interns may be offered a full-time permanent position at cynapse at the end of the internship period.

Responsibilities
The selected candidate will be involved in one or more job items listed below, depending on management decision:

• Supporting the planning and delivery of Vision AI Software Projects/Programs in Singapore and other countries
• Support multiple ongoing projects
• Assist with the project planning, resourcing and scheduling
• Assist in ensuring that projects are delivered on time, and provide timely reports on project status and activities Assist in requirements gathering and validation, solution development and testing, deployment, UAT and solution commissioning
• With guidance, perform usage tests on software thoroughly, identifying bugs and defects.
• Evaluate different functionalities and aspects of the product and generate reports.
• Assist in communicating and managing vendors, sub-contractors, partners and other stakeholders
• Follow the company PM best practices
• Work in an Agile environment (SCRUM)

Qualifications

• Completed at least 1 year of studies as part of a Diploma/Bachelor/Master in one of the following subjects: IT/Engineering/project management
• At least 6 months of experience in managing or delivering IT project/s
• Some Experience with vendors and partner management
• Analytical Thinking
• Innovative, motivated and a quick learner, attention to detail, curiosity, and passion for technology
• Bonus: Technical background/experience with software development

Benefits

• Unique opportunity to work with a talented global team on cutting-edge technologies
• Informal and exciting work environment with flexible hours

Job Types: Full-time, Internship

Contract length: 6 months

Benefits:

• Flexible schedule

Schedule:

• Monday to Friday

Work Location: In person

• Devising and implementing methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
• Designing and analysing inspection and testing processes, mechanisms, and equipment
• Conducting quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks
• Undertaking root cause analysis of incidents requiring corrective action
• Ensure that corrective measures and deviation meet acceptable reliability standards
• Other ad hoc duties assigned

Requirements

• API Q1 and Q2 certifications
• Internal audit certification

Interested applicants may email resume to [email protected]

Jessie Hoe Huey Miin (CEI Registration No: R1103861)

Recruit Express Pte Ltd (EA: 99C4599)