Support day-to-day training administration for the Company. Interacts with all levels of staff in the Company with regards to in-house training, external training, on-the-job training and education.

Training Needs Analysis and Training Plan

• Compile the Training Needs for the year
• Analyze the training needs of staff and develop a total training plan yearly
• Educate or provide awareness training on Training Needs Analysis as required

Training Management and Communication

• Upkeep of all staff training records
• Conduct/Coordinate on training such as ISO9000, AS9100, ISO14000, OHSAS18001, Technical training, Soft Skills & etc.
• Assist in program design and development for in-house training
• Source, evaluate and engage external consultants for selected training programs
• Create training awareness & schedule through internal promotion, intranet & etc.
• Liaise with government institution for training grants or subsidies
• Review and recommend policies and procedures to increase the effectiveness and efficiency of the people development functions
• Control and monitor the total training budget for the company
• Set up an information system for the people development function to provide pertinent feedback to management

Training Evaluation

• Compile all training evaluation results after each training
• Provide monthly reports on training results, expenditure & etc.
• Develop and evaluate all four levels of training and ensure prompt feedback of information
• Provide half-yearly training report on the Total Training Plan and its effectiveness
• Comply with the ISO9001, AS9100, ISO4001 & OHSAS18001 Management system

Other Tasks

• Familiar with Quality Control Circle criteria and able to conduct and facilitate the teams.
• In charge of Staff Suggestion Scheme and ensure all employees to participate during Quality month
• Involve in GHG reduction activities
• Submit OHS & HSE data to HQ quarterly
• Other tasks assigned by superior.
• Ensure implementation of people development policies and procedures
• Timely compilation of Training Needs Analysis of the company yearly
• Implementation of training identified in the Total Training Plan
• The Company Education budget is appropriately used

Requirements:

• Degree in Business Administration with 2 years related experiences or Diploma in Training & Development with 4 –5 years training experience
• Possess good interpersonal skills
• Good oral & written communication skills
• Able to work as a team player
• Knowledge in People Developer Standard & it’s requirements
• Computer literate & proficient in MS Office
• Good understanding of Training Fund on all government statutory board requirements
• Stand up training experience is essential.

5 days work week

Bedok Area

Manufacturing Co.

Interested candidates, please forward a detailed resume and email to [email protected]

Tempserv Pte Ltd
License No: 06C3745
Attention: Audris Teo / EA Personnel No: R1102063

Job Description

• Basic Up $2500
• Mon to Friday (Office Hours)
• AWS+VB
• East

Job Responsibilities

• Inspect aircraft spares
• Verify aircraft spares to ensure appropriate accompanying documents from the OEMs, vendors and suppliers
• Work on continuous improvement projects to improve work areas & procedures
• Facilitate periodic audits from civil aviation authorities & customers
• Maintain Shelf Life records for aircraft spares with limited life
• Monitor and conduct surveillance audits on all stores activities within the Bonded Stores
• Raise Discrepancy Reports for any discrepancies found on any aircraft spares in the Bonded Stores

Interested Applicants, kindly WhatsApp me at +65 8500 3939 or email me at [email protected]

We regret to inform that only shortlisted candidates will be notified.

EA Personnel Name: Chin Jia Hui, Janice
EA Personnel No: R22107485
EA License No: 15C7752

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

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

Job Description

1. Data Protection Compliance:

• Assist in reviewing, updating, and maintaining data protection policies and procedures.
• Ensure organizational practices comply with data protection regulations (e.g., GDPR, CCPA).

2. Data Inventory and Mapping:

• Help update and maintain records of processing activities (ROPAs).
• Assist in mapping data flows to identify risks and gaps.

3. Data Protection Impact Assessments (DPIAs):

• Support in conducting Data Protection Impact Assessments (DPIAs) for new or existing processes.

4. Training and Awareness:

• Help coordinate data protection training sessions for employees.
• Develop awareness materials on privacy and data security practices.

5. Incident Response:

• Assist in responding to data breaches, including investigation, documentation, and reporting.
• Ensure incidents are escalated to appropriate teams when necessary.

6. Auditing and Monitoring:

• Assist in internal audits and drills to identify data protection compliance gaps.
• Provide administrative support for external audits.

7. General Administrative Tasks:

• Maintain accurate records of all data protection-related activities.
• Prepare reports and presentations as required.

Job Requirements

• Minimum Diploma in a relevant discipline, preferably Degree in any discipline.
• Preferably undergone Fundamentals of PDPA and/or Practitioner Certification in Personal Data Protection.
• Experience in compliance/audits especially data protection compliance.

Apply now by sending your resume to [email protected]

We regret to inform you that only shortlisted candidates will be notified.

Ashley Loo | R2095115 | EA License Number: 99C4599

Recruit Express Pte Ltd Company Reg. No. 199601303W

Mon to Fri 8.30am - 6pm

Position Summary

This position play a critical role in driving compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Job Scope

1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for company’s Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others.

2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.

3. Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management: Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs: Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.

7. Certification Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region.

8. Operations & Customer Audit Programs: Lead & prepare for regular audit programs / random checks / regulatory activities to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison: Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and resolve issues via conducting root cause analysis.

10. Healthcare Quality Feedback: Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs: Lead the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

12. Depot Support: Provide secondary / backup support to healthcare specialists for market depots.

Requirements :

1. Hold local pharmacist license

2. Have at least five (5) years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry

3. Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

4. Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices, IATA CEIV and other local certifications in a warehouse and transportation business.

5. Experience in conducting external and internal audits for regions

6. Must hold at least Bachelor’s degree in Pharmacy from a reputable local or Australia’s institute.

7. This position require to communicate with counter part in China

8. Occasionally travel is required to sites and region warehouses.

Competency

1. Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards

2. Problem-solving skills to support customer issue resolution

3. Planning & organization skills to ensure proper audit programs are managed effectively

4. Communication skills to facilitate engagements with customer and regulatory agencies

5. Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking

6. Apply data-driven decision making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint

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.

whatsapp: 85986715

singaporean,PR can apply

Daily cosmetic raw material production platform: quality director

Location: Johor Bahru, Malaysia

Recruitment Position： Quality Director

Job Responsibilities

1 review and approve all appropriate quality-related documents;

2 Releasing or rejecting all APIs. Releasing or rejecting intermediates for use outside the control of the manufacturing company;

3 Establishing a system to release or reject raw materials, intermediates, packaging and labelling materials;

4 Making sure that critical deviations are investigated and resolved;

5 Approving all specifications and master production instructions;

6 Approving all procedures impacting the quality of intermediates or APIs;

7 Making sure that internal audits (self-inspections) are performed;

8 Approving intermediate and API contract manufacturers;

9 Approving changes that potentially impact intermediate or API quality;

10 Reviewing and approving validation protocols and reports;

11 Making sure that quality related complaints are investigated and resolved;

12 Making sure that effective systems are used for maintaining and calibrating critical equipment;

13 Making sure that materials are appropriately tested and the results are reported;

14 Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate;

15 Performing product quality reviews.

Job Requirements

1 University or academic degree in chemistry, biology, pharmacy or equivalent.

2 Proficient in English required.

3 Minimum of 7 years’ experience in pharmaceutical factory, in Manufacturing, and QA Manager for 5 Years at least; with a thorough knowledge in chemistry, pharmacy and/or biotechnology.

4 Familiar with ICH Q7 guidelines and have accepted FDA, EDQM audit experience.

5 Profound experience leading sophisticated quality organizations in a diverse global matrix environment，Ability to speak up and to take Quality decisions during challenging situation.

6 Strong leadership skills with excellent interpersonal, communication abilities.

7. can speak simple chinese and english

Salary: $10000-$15000 singapore dollar

Jie Shun Jia | EA License No.: 24C2410 | EA Registration No.: R24124440 (FENG YINGJIE)

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

Duties

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

Requirements

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

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

We regret that only shortlisted candidate will be notified.

Email Address: [email protected]

Recruitpedia Pte. Ltd.

EA License No: 19C9682

EA Reg. No. R23115141 (Tan Su Yee)

• 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

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

Duties

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

Requirements

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

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

We regret that only shortlisted candidate will be notified.

Email Address: [email protected]

Recruitpedia Pte. Ltd.

EA License No: 19C9682

EA Reg. No. R23115141 (Tan Su Yee)

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

Responsibilities:

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

Requirements:

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

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

We regret that only shortlisted candidate will be notified.

Email: [email protected]

Recruitpedia Pte. Ltd.

EA License No. 19C9682

EA Reg. No. R2198636 (Oh Puey Xin)

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.

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

Responsibilities:

The primary responsibility of this position is to provide leadership for all Quality Assurance & Control matters.

• Assuring consistent quality of production by developing processes and enforcing compliance to ISO 13485 quality system.
• Validating the production & inspection processes and maintaining validation status
• Managing the records for Quality Inspection, Quality Control, Calibration, QA Lab equipment, Training Resources, ERP Quality Module and Quality System Documentation.
• Managing a team of Engineers, QA Technicians & Quality Inspectors

Requirements:

• Bachelor’s in Engineering or Science / Master’s in Engineering or Science
• Extensive experience within a manufacturing environment with a thorough understanding of ISO 13485 and ISO 9001.
• Six Sigma certification and/or ASQ certified Quality Engineer

HOW TO APPLY:

Interested applicants, kindly click on “APPLY NOW” or send your resume in MS WORD format to hestia.wong(at)trustrecruit.com.sg

We regret only shortlisted candidates will be notified.

Important Note: Trust Recruit Pte Ltd is committed to safeguarding your personal data in accordance with the Personal Data Protection Act (PDPA).

Please read our privacy statement on our corporate website www.trustrecruit.com.sg.

Trust Recruit Pte Ltd

EA License No: 19C9950

EA Personnel: Wong Ying Huan (Hestia)

EA Personnel Reg No: R24122431