Total 1,116 talent acquisition specialist job vacancies in Quality Assurance / Control category in Malaysia

Functions:

1. To manage the regulatory compliance function of the company, which include medical device registration, post market surveillance, clinical evaluation.
2. To ensure compliance with regulatory requirements from countries / regions such as the EU (MDR), US (FDA), Malaysia (MDA) and so on.
3. To develop and maintain Technical Documentation for each medical device category.
4. To participate in developing and maintaining Standard Operating Procedures, Work Instructions and Specifications that comply with the relevant regulatory and customer requirements.
5. To keep abreast of the regulatory changes and its implications, keeping management apprised at all times.

Profile:

1. Degree / diploma in medical, engineering, science or regulatory field
2. A minimum of 2 years' experience in regulatory affairs in the medical device industry
3. Practical experience in dealing with regulatory bodies (Malaysia MDA or foreign authorized representative such as the EU)
4. Good organization skills and proactive in ensuring regulatory requirement are met.
5. Good communication skills to maintain communication with external and internal stakeholders.
6. Good written skills in English.
7. Auditing experience in ISO 13485 or GDPMD will be and added advantage.

Perks & Benefits

• Medical insurance
• Personal leave

Position subject to a 5-day minimum on-site work requirement per 10-day pay period.

Applicants should apply to the location(s) they are able to regularly report to. Location will be determined once selection(s) is made. Salary posted reflects pay range for all locations. Once the selection has been made, the salary will be set in accordance with the selectee's location.

The positions can be filled in any of the following locations:

• Chicago, IL: $80,994 - 126,198
• Columbus, OH: $75,646 - $117,866
• Detroit, MI: $80,006 - $124,659
• Indianapolis, IN: $73,218 - $114,082
• Kansas City, MO $73,690 - $114,818
• Milwaukee, WI: $75,864 - $118,205
• Minneapolis, MN: $78,969 - $123,043
• Omaha, NE: $73,249 - $114,131
• St. Louis, MO: $74,299 - $115,766

• Assists in planning, developing, and implementing the region's outreach program.
• Represents the region at contractor meetings, seminars, and workshops.
• Identifies and maintains working relationships with public and private stakeholders (federal contractors, industry liaison groups, trade/industry associations, chamber of commerce, educational institutions, and others) to promote equal employment opportunity and the concept of voluntary compliance with Office of Federal Contract Compliance Programs (OFCCP) Equal Employment Opportunity (EEO) regulations.
• Promotes voluntary compliance; keeps the public aware of changes in the equal employment opportunity rules and requirements regarding E.O. 11246, Section 503, the Americans with Disabilities Act, and VEVRAA; makes public presentations; serves on panels in seminars, conferences, and EEO compliance meetings.
• Conducts public demonstrations of OFCCP computer-based and/or Internet outreach materials to further public knowledge and use of materials interpreting equal employment opportunity standards and regulations. Coordinates outreach efforts for and works with first-time contractors.
• Fosters creative partnerships with federal contractors, linkage organizations and other federal contracting agencies, industry liaison groups, trade associations, and others interested in equal employment opportunity.
• Participates in compliance evaluations and complaint investigations.
• Develops strategies for investigation or data collection and analysis, conciliates issues, negotiates with officials, and may use precedents to draft remedies for discriminatory practices and other noncompliance designed to correct the violation(s).

Position subject to a 5-day minimum on-site work requirement per 10-day pay period.

Applicants should apply to the location(s) they are able to regularly report to. Location will be determined once selection(s) is made. Salary posted reflects pay range for all locations. Once the selection has been made, the salary will be set in accordance with the selectee's location.

The positions can be filled in any of the following locations:

• Chicago, IL: $80,994 - 126,198
• Columbus, OH: $75,646 - $117,866
• Detroit, MI: $80,006 - $124,659
• Indianapolis, IN: $73,218 - $114,082
• Kansas City, MO $73,690 - $114,818
• Milwaukee, WI: $75,864 - $118,205
• Minneapolis, MN: $78,969 - $123,043
• Omaha, NE: $73,249 - $114,131
• St. Louis, MO: $74,299 - $115,766

• Assists in planning, developing, and implementing the region's outreach program.
• Represents the region at contractor meetings, seminars, and workshops.
• Identifies and maintains working relationships with public and private stakeholders (federal contractors, industry liaison groups, trade/industry associations, chamber of commerce, educational institutions, and others) to promote equal employment opportunity and the concept of voluntary compliance with Office of Federal Contract Compliance Programs (OFCCP) Equal Employment Opportunity (EEO) regulations.
• Promotes voluntary compliance; keeps the public aware of changes in the equal employment opportunity rules and requirements regarding E.O. 11246, Section 503, the Americans with Disabilities Act, and VEVRAA; makes public presentations; serves on panels in seminars, conferences, and EEO compliance meetings.
• Conducts public demonstrations of OFCCP computer-based and/or Internet outreach materials to further public knowledge and use of materials interpreting equal employment opportunity standards and regulations. Coordinates outreach efforts for and works with first-time contractors.
• Fosters creative partnerships with federal contractors, linkage organizations and other federal contracting agencies, industry liaison groups, trade associations, and others interested in equal employment opportunity.
• Participates in compliance evaluations and complaint investigations.
• Develops strategies for investigation or data collection and analysis, conciliates issues, negotiates with officials, and may use precedents to draft remedies for discriminatory practices and other noncompliance designed to correct the violation(s).

About BullionStar:
BullionStar is a trusted and premier bullion dealer in the precious metals industry, providing customers with a convenient and secure platform to buy, sell, and store bullion. With a strong focus on transparency and regulatory compliance, we are committed to maintaining the highest standards of integrity in all our operations.

Job Summary:
BullionStar is seeking an experienced and detail-oriented AML Compliance Specialist to join our team. The successful candidate will be responsible for ensuring that BullionStar adheres to all applicable Anti-Money Laundering (AML) regulations and guidelines, implementing effective AML controls, and supporting the continuous improvement of our compliance framework.

Key Responsibilities:

• AML Management: Provide support to develop, implement, and maintain the company’s AML policies, procedures, and controls to ensure compliance with MAS regulations and local legislations.
• Transaction Monitoring: Conduct transaction monitoring to detect and report suspicious activities. Review and analyse alerts generated by our AML monitoring system.
• KYC/Customer Due Diligence: Conduct Know Your Customer (KYC), Customer Due Diligence (CDD), and Enhanced Customer Due Diligence (ECDD) processes for new and existing customers. Review information and documentation received, ensuring accuracy and compliance with regulatory requirements. Approve or escalate cases as needed to ensure proper risk assessment is completed before allowing transactions to proceed.
• Customer Liaison: Work directly with customers to guide them through KYC/AML documentation processes, answer inquiries, and ensure compliance is maintained.
• Reporting: Prepare and submit Cash Transaction Reports (CTRs) and Suspicious Transaction Reports (STRs) to the relevant authorities in a timely manner.
• Training & Awareness: Provide regular AML training and guidance to employees to enhance their understanding of AML obligations and best practices.
• Regulatory Reporting: Ensure accurate and timely submission of regulatory reports and filings as required by MAS and other regulatory bodies.
• Continuous Improvement: Stay updated on changes in AML laws, regulations, and best practices. Recommend and implement enhancements to the AML compliance framework.
• Collaboration: Work closely with other departments, including stakeholders, legal, and operations, to ensure a cohesive approach to compliance.

Qualifications:

• Diploma in Finance, Business, Law, or any related field.
• Minimum of 2-3 years of experience in AML compliance, preferably within the financial services or precious metals industry.
• Strong knowledge of MAS AML/CFT regulations and PEP screening.
• Experience with transaction monitoring systems and KYC/CDD/ECDD processes.
• Excellent analytical skills and attention to detail.
• Strong communication and interpersonal skills, with the ability to train others.

Location

The job location is at 45 New Bridge Road. This bustling location is located in between Chinatown and Clarke Quay with the Clarke Quay MRT located just across the road making commuting easy.

Salary and Benefits

The salary is dependent on your capability, experience and skills. The typical starting salary is from SGD 3,000 to SGD 5,000 per month for a driven candidate plus up to three month's bonus salary. BullionStar furthermore offers reimbursement of medical bills and access to an employee health and fitness benefit program.

• Serves as a team leader for a quality assurance team, assigning work, providing feedback, checking progress, arranging training for team members, and providing input to supervisor.
• Reviews contracts to identify specification requirements needed from contractors.
• Communicates with contractors to ensure contractual compliance of contractor processes.
• Assesses contractor/subcontractor/vendor quality assurance controls; then adjusts product audits.
• Creates risk management program to mitigate the Governments risk by analyzing data/contractual requirements, preparing surveillance plans, and addressing specific customer/Organizational requirements.
• Evaluates supplier quality systems using data validation, post-award first article meetings, and suppliers test reports, then recommends dis/approval to contracting officers.
• Evaluates suppliers responses to quality issues and requests corrections
• Retains relevant data, correspondence, audits, etc.

• Ensure contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Independently applies a wide range of methods, principles, and practices directly related to the quality control/quality assurance fields such as statistical analysis,...
• ...control and sampling, and quality data analysis and evaluation to determine contractor compliance.
• Incorporates a thorough and detailed QA knowledge in applying various methods and techniques for investigating, analyzing, and ensuring corrective action on complex quality problems.
• Develop and implement a surveillance plan which begins with clear objectives supported by a master schedule that includes identification of contractor and sub-contractor production needs.
• Independently perform audits/surveillance of contractor’s processes to ensure customer and contractual requirements are met.

Job Descriptions:

• Management of CAPA from tracking, including follow-ups and closure.
• Management of Change Control, Deviations, from tracking, follow-ups and closure.
• Review quality process control plan, drive quality issues to root cause, corrective actions and improvements.
• Perform, document internal audits and other quality assurance activities to ensure readiness on international standards certification audits and GMP inspection.
• Coordinate and assists during customer visits and audits.
• Create, review work instructions and standard operating procedures, devise sampling procedures and directions for recording and reporting quality data.
• Review the implementation and efficiency of quality and inspection systems.
• Collect, compile statistical quality data, and analyze data to identify areas for improvement in the quality system.
• Review of analytical reports, and batch records (manufacturing and packaging).
• Perform SAP QM setting, review test results, block / unblock of finished products.
• Manage customer queries, customer satisfaction surveys, and questionnaires and other quality / regulatory purpose documentation requests.
• Investigate customer complaints and non-conformance issues.
• Consolidate data to create the annual product quality review report.
• Track quality performance and initiate quality improvement plans.
• Perform risk assessments and monitor risk management activities at quality level.
• Conduct /perform training to employees to improve GMP / international standards certification awareness and compliance.
• Perform any other duties and responsibilities as assigned from time to time.

Job Requirements:

• Minimum 2 years related work experience
• Possess experience in internal audit, validation activities, training management and batch release for API with good background on cGMP

Responsibilities

• Support Global Customs & Trade Compliance team with Import and Export Classification (HTS and ECCN), Customs Valuation, or any other topics, focusing on the region but also from a Global standpoint.
• Enforce procedures to ensure restricted party screening is conducted on all transactions, including domestic transactions, to include customers, freight forwarders, suppliers, etc.
• Support the region/subsidiaries on understanding, management and application of customs & trade related documentation (CoOs, import permits, etc.).
• Proactively identify and drive process improvement initiatives and devise and implement strategic plans to optimize import/export activities in the Asia Pacific region.
• Support with import and export classification, based on national regulations/interpretations of the WCO, EAR, and in alignment with the Global Customs & Trade Compliance team. Retain audit trails to support the classification assigned and update the classification database system.
• Support and assist with the implementation with any global and/or local/regional project/process that comes up, by being a strong contributor and showing enthusiasm to work as a team player - from both the Customs & Trade team (globally) and from the subsidiaries within the Region.
• Perform Trade Compliance Import and Export Audits as needed.
• Provide advice and hands-on assistance on projects involving the use of Free Trade Agreements (FTAs), customs valuation and transfer pricing, and applying for trade schemes provided by Singapore Customs and other related authorities.
• Undertake Denied Party Screenings and evaluate potential matches and release holds.
• Identify import/export compliance issues and escalate them as appropriate.
• Support the Company’s Business Units (BUs) across the Asia Pacific region concerning day-to-day questions regarding customs and indirect taxes (GST/VAT)
• Work with other departments, including Finance, Tax, Logistics, and BUs to advise on indirect tax and customs matters arising from business changes or proposed transactions (e.g., import and export considerations, FTA optimization, bonded warehouses, GST/VAT impact).
• Develop communication and training plans to raise awareness among stakeholders on customs and indirect taxes and compliance processes.

Experience Requirements

• Minimally possessing a Bachelor of International Business or related discipline preferred
• Minimum 7 years of experience with Customs and Trade compliance in US and APAC Region
• Strong working knowledge of import/export regulations, controls, and trade compliance practices within Asia as well as US-China export controls
• Working knowledge of the Harmonized Tariff Schedule and Classification.
• Working Knowledge of Commerce Control List and Dual Use Goods List and Classification
• Experience with import and export license determination, regional free trade agreements, special customs authorizations, and customs security programs
• Certified Custom Specialist or Licensed Customs Broker is preferred.
• Strong technical knowledge and understanding of complex supply chain concepts and ability to effectively apply customs and indirect tax knowledge to the Company’s business.
• Comprehensive and up-to-date knowledge of customs and indirect tax laws and requirements in more than one jurisdiction in the Asia Pacific region (preferably with a focus on Northeast Asia)
• Excellent written and verbal communication skills
• Effective problem-solving skills and ability to partner closely with internal key stakeholders, e.g., logistics, sales, R&D, manufacturing.
• Solid knowledge and experience working with MS Office applications, Power Point and Global Trade Management systems.
• Excellent knowledge of Oracle will be advantageous.
• Willing to travel for work purposes.
• Possess excellent planning, communication, interpersonal, organizational and analytical skills.
• Able to work independently with minimal direction.
• Fluency in English and one other Asian language (preferably Mandarin)

• Ensure contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Apply a wide range of methods, principles, and practices directly related to the quality control/quality assurance fields such as statistical analysis, control and sampling, and quality data analysis and evaluation to determine contractor compliance.
• Incorporate a thorough and detailed QA knowledge in applying various methods and techniques for investigating, analyzing, and ensuring corrective action on complex quality problems.
• Develop and implement a surveillance plan which begins with clear objectives supported by a master schedule that includes identification of contractor and sub-contractor production needs.
• Independently perform audits/surveillance of contractor’s processes to ensure customer and contractual requirements are met.

• If selected at the GS-09 level, duties will be performed in a developmental capacity.
• Performs duties associated with the administration of the quality assurance provisions of contracts by designing, implementing, and maintaining a risk-based surveillance program and assessment plan.
• Identifies opportunities for process improvements through analysis of process measurement data.
• Serves as a member of a multi-functional or technical team. Responsible for implementing the overall Quality Program for a diversity of products and services in support of U.S. Government acquisition at one or more suppliers facilities.
• Ensures contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Independently performs audits/surveillance of contractors processes to ensure customer and contractual requirements are met.
• Investigates and provides data on customer complaints/concerns regarding contractors quality performance and processes which impact user satisfaction.
• Provides technical support to all other DCMA team members, assisting in the analysis of contract related issues to determine the best course of action to support the contractor and customers.

As a Policy Governance specialist within the Center of Excellence (PGA), your primary responsibility will be to develop, implement, and govern policies and procedures that ensure compliance, consistency, and best practices across the organization. You will work closely with cross-functional teams to establish policy frameworks, review and update policies, and ensure adherence to policy requirements. This role requires strong knowledge of policy management, attention to detail, and the ability to collaborate with stakeholders at all levels.

Key Duties and Responsibilities

• Policy Governance: Collaborate with stakeholders to develop and maintain a comprehensive policy framework for the PGA. Identify policy needs, research industry best practices, and draft policies and procedures that align with organizational goals and regulatory requirements.

• Policy Management: Facilitate the implementation of policies across the organization. Work closely with functional teams to ensure understanding and compliance with policy requirements. Develop communication plans and training materials to promote policy awareness and adherence.

• Policy Cascade and Awareness: Regularly review existing policies and procedures to ensure relevance, effectiveness, and compliance with changing regulations and business needs. Engage stakeholders in policy review discussions, solicit feedback, and incorporate revisions as necessary.

• Policy Governance Guidelines and Procedures: Establish and maintain a governance process for policy management, including policy creation, review, approval, and dissemination. Define roles and responsibilities for policy owners, reviewers, and stakeholders involved in the policy governance process.

• Policy Stewardship: Develop communication strategies and materials to effectively communicate policies and procedures to the organization. Conduct policy training sessions to ensure employees understand their responsibilities and obligations under the policies.

• Policy Adherence Metrics: Monitor policy compliance across the organization. Establish mechanisms for tracking and reporting policy violations or non-compliance. Collaborate with compliance and internal audit teams to address policy breaches and implement corrective actions.

• Document Management: Maintain an organized and up-to-date repository of policies and procedures. Ensure policy documents are easily accessible, well-structured, and properly versioned. Implement document control processes to manage policy changes and updates.

• Policy Mapping and Refinement: Collaborate with cross-functional teams, process owners, and subject matter experts to gather input, align policy requirements, and ensure policy consistency across the organization. Engage stakeholders in policy-related discussions and initiatives.

• Process Improvement: Continuously improve the policy management process and related tools. Stay updated on regulatory changes, industry best practices, and advancements in policy governance methodologies.

• Policy Governance Reporting: Generate and distribute regular reports and metrics on policy, guidelines, and process compliance, and. Provide insights and recommendations for improving adherence of stakeholders to the approved policy and guidelines.

• Performs duties associated with the administration of the quality assurance provisions of contracts by designing, implementing, and maintaining a risk-based surveillance program and assessment plan.
• Identifies opportunities for process improvements through analysis of process measurement data.
• Serves as a member of a multi-functional or technical team. Responsible for implementing the overall Quality Program for a diversity of products and services in support of U.S. Government acquisition at one or more supplier’s facilities.
• Ensures contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Independently performs audits/surveillance of contractor’s processes to ensure customer and contractual requirements are met.
• Investigates and provides data on customer complaints/concerns regarding contractor’s quality performance and processes which impact user satisfaction.
• Provides technical support to all other DCMA team members, assisting in the analysis of contract related issues to determine the best course of action to support the contractor and customers.

• Under the guidance and direction of higher grade team leader, prepares contract specifications and technical exhibits for simplified contracts, as assigned by the team leader, and develop contract modifications for existing contracts.
• Reviews plans, sketches, blueprints, other similar technical information, and input from both customers and other DPW personnel to prepare contract requirements.
• Submits reports of documented instance of unacceptable contractor performance and contractor's failure to comply with contractual provisions.
• Based on contractual workload, determines valid changes and recurring requirements brought on by changes in procedures and operations.
• Determines effectiveness of contractor’s response to procedural and operational changes required by modifications to current regulations.

• Advises on the development of contract requirements to ensure performance work statements, Performance Requirements Summaries, and Quality Assurance Surveillance Plans are commensurate with contract oversight and administration.
• Identifies deficiencies by analyzing the Government, contractor, and customer quality data and requesting appropriate corrective action when deficiencies or trends are indicated.
• Provides functional and technical interpretation and advice on regulations, contract management, and guidance on quality assurance issues and problems.
• Assist in the development of Installation Contracting Office operating procedures in quality assurance.
• Perform solicitation reviews to ensure appropriate quality control requirements are imposed and assist in the preparation of technical specifications for inclusion in procurement solicitation packages.
• Provides Contracting Office personnel quality assurance training and instruction.
• Provides Contracting Officer Representative (COR) MICC Enhanced COR Training.