Driven by the passion to improve the quality of people’s lives, WS Audiology continues to grow as the market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation to reach more people, more effectively.

Join our Business Quality team as a QMS Specialist based in our Singapore office at Tai Seng. You will play a crucial role in ensuring medical device regulatory compliance for products released to the market and oversee Singapore quality management system maintenance and continuous improvement initiatives.

What you will do

• Document controlImplement and coordinate local Document Control according to internal and legal requirements, such as ISO 13485.
  Ensure adherence to global documents while minimizing local documents, ensuring they align with global standards.
  Participate in and moderate local change board meetings.
  Train and consult team members on Good Documentation Practices (GDP) and process requirements.
  Conduct local meetings to inform stakeholders about document revisions or new releases.
  Maintain a local overview of Quality Management System (QMS) documents, including archiving and revision control.
  Track QMS Change Requests and perform reviews and approvals of revisions or new documents.
  
• Quality Improvement TeamCoordinate and support local Quality Improvement Teams (QIT), acting as the QIT leader.
  Document and archive input from Quality Improvement Team Meetings.
  Follow up on action items resulting from Quality Improvement Team Meetings.
  
• Quality Representative (QS)Prepare and coordinate local Management reviews.
  Act as a Quality Management (QM) Auditor, conducting internal audits.
  Establish, consult, and train management and employees on the Quality System.
  
• Local Training OfficerImplement the training concept locally based on global requirements, additional regulatory requirements, and ISO 13485 standards.
  Train administrators on the training tool.
  Maintain data alongside administrators and update the training matrix in case of revisions.
  Track training status, monitor Key Performance Indicators (KPIs), and perform data analysis.
  Archive quality-relevant training records as needed.
  
• Local Audit ManagementServe as the main contact person for all internal and external Quality Management System (QMS) audits in Singapore.
  Coordinate, prepare, and follow up on audits, aligning plans and agendas with auditees and auditors.
  Coordinate logistical aspects, including organizing facilities and following up on audit findings and improvements.
  
• Ad HocSupport APAC countries on Doc. Control, Training, Product Registration
  

What you bring

• 3 years of relevant experience in QMS within the Medical Device Industry
• Eagerness and willingness to learn, demonstrating a proactive approach to professional development.
• Team Player and ability to perform effectively under pressure delivering high-quality results even in challenging situations.
• Internal Auditor Qualification

Who we are

At WS Audiology, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

Sounds wonderful? We can't wait to hear from you.

WS Audiology is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.

As an Area Sales Specialist for Electrification business, you will be responsible for the sales of products/systems/services within a designated market/division, in line with the division strategy.

Reporting to Sales Manager, you will be achieving both qualitative and quantitative sales targets to ensure sustainable order growth, revenues, profitability, market share, and customer satisfaction.

Responsibilities:

• Selling products/systems/services to customers, focusing on volume, mix, and profitability targets for the assigned divisions.
• Establishing and maintaining effective customer relationships to understand their needs, promotes their understanding of ABB’s complete product/systems/ services offering, and aligns with them to provide a solution.
• Ensuring a positive customer experience throughout the sales process.
• Preparing sales plans using ABB authorized tools. Performing regular status reviews and proposes recovery plan(s), in case of any potential order shortfalls.
• Creating added value for the customer and ABB and ensuring the successful outcome of transactions, contracts, and proposals, by using effective sales techniques.
• Communicating to the customers about the details related to delivery time, payments, and general terms and conditions, in line with ABB’s offering and strategy.
• Ensuring efficient marketing activities and communicates value proposition to customers.
• Identifying and driving the development of new market opportunities in the designated market.

Requirements:

• Degree in Electrical Engineering with ideally some years of Sales experience
• A Self-starter
• Knowledge in cable protection/management products and Earthing & Lightning protection systems
• Knowledge in Medium Voltage (MV) applications and products is an added advantage
• Willing to travel 50%

Job Description:

Internal Processes and Reporting

1. Establish and maintain Quality Management System in both local and SEA region.
2. Develop or update procedures and SOPs for quality system process to ensure continuous process improvement is met.
3. Support audit readiness, conduct and prepare for regulatory or external audit as well as internal quality audits to ensure timely execution according to defined schedules.
4. Execute recall or field corrective actions and other post-market surveillance activities within impacted countries in the SEA region.
5. Participate in handling non-conformity, corrective and preventive actions, documentations, supplier quality across the organization’s sites.
6. Assist administration of management review process, including maintaining compliance to quality system data metric analysis, monitor and trend quality indicators to proactively report or escalate issues to QRA manager.
7. Track and monitor both Singapore and Regional KPIs including QA performance and develop monthly and/or quarterly analysis and reports for reporting to Management.
8. Execute other tasks and projects, as assigned by QRA manager.

Project Support, Training and Continuous Improvement

1. Provide QA support to new business development projects for potential or new onboarding customers.
2. Conduct training (both internal and refresher training) on standards and procedure, quality related programs and quality management procedure.
3. Conduct process mapping and identify areas of improvement and implement steps required to improve processes within QA and other functions.
4. Responsible for planning and implementation of QA related projects.

Minimum Qualifications:

• Degree holder in Life science, biomedical engineering-related field or equivalent experience.
• Strong attention to details.
• Excellent communication and interpersonal skills with ability to work collaboratively and influence cross-functional team.
• Able to converse in proficient Chinese.
• Problem-solving mindset and the ability to drive continuous improvement.
• Familiar with GDP and GDPMDS is a plus.
• Familiar with quality management methodologies (e.g., Six Sigma, Lean, Root Cause Analysis) is a plus.
• Having quality assurance experience is a plus.

Benefits & Highlights:

• Work Style: Hybrid/Flex
• Location: Buona Vista
• Great employee benefit
• Weekly office lunches
• Reporting Line: Regulatory Manager, APAC

About the Role :-

This role will advance Regulatory Affairs (RA) functions by planning and driving initiatives focused on continuous improvements and operational excellence of regulatory systems and processes, as well as creating and maintaining mechanisms for rapid tactical execution of regulatory tasks. With a strong focus on Regulatory Information Management and Analysis, playing a key role in aligning processes and facilitating the effective execution of regulatory related activities; helping to ensure the right level of cross-functional transparency and accountability through the regulatory process.

• Supporting, and at times, driving the initiative for the effective implementation of a Global Regulatory Information Management System (RIMS) within APAC to facilitate the centralisation of common documentation in support of global registration activities and processes.
• Supporting business needs by liaising with internal partners, Regulatory team, IT, and vendors to identify technical solutions and for translating RA processes into executable workflows
• Maintaining traceability from RA information through the decision-making process into materialised outputs
• Anticipating regulatory or related obstacles and emerging issues throughout the product lifecycle, leveraging and developing a mechanism for regular review and associated actions
• In accordance with evolving regulatory requirements and trends, participating, and at times, driving system and process improvement projects, including but not limited to new regulatory policies, processes and SOPs, ensuring appropriate collaboration with stakeholders.

Education and Experience:

• Degree qualified preferably in a Science or Engineering discipline.
• Training in technical operational aspects of Regulatory Affairs, with at least 3 years of direct Regulatory Affairs experience within a medical device company preferably with Orthopaedics
• Able to work independently as well as part of a cross-functional team, with exceptional written and oral communication skills and the ability to successfully build effective working relationship.
• Regulatory Affairs Certification (RAC) an added bonus
• Ability to read and comprehend scientific literature to collect data, establish facts, draw valid conclusions and produce scientifically supported documentation.
• Experience with MS Office as well as SAP

About Arthrex

Arthrex is a global medical device company and leader in new product development and medical education in Orthopaedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year. We are a privately held company with a family business culture committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.

Job Description:

1. Review, assess and process safety data and information on timely and accurate manner received from various sources and distribute reports/ dates internally and for regulatory agencies in local and regional setting.
2. Determine initial / follow up status of incoming events.
3. Assist in the preparation of pharmacovigilance documentation for regulatory submission, including periodic safety reports and risk management plans.
4. Perform Pharmacovigilance activities as per product categories requirements including but not limited to, collecting and tracking incoming AE / endpoint information.
5. Assist in the preparation of medical information materials and providing support for medical inquiries.
6. Participate in the development and delivery of pharmacovigilance training programs for internal staff and external stakeholders.
7. Work closely with Medical Scientific Affairs department to perform and follow up causality assessments for reported adverse event (AE).

Minimum Qualifications:

• Degree holder in Pharmacy, Life science or equivalent experience.
• Familarity with coding dictionaries (MedDRA) is a plus.
• Strong attention to details.
• Excellent communication and interpersonal skills with ability to work collaboratively and influence cross-functional team.
• Able to converse in proficient Chinese.
• Strong verbal / written communication skills.
• Able to follow instruction/ guidelines, utilise initiative and work independently.
• Experience in case processing, safety reporting and risk management activities.
• Able to multitask, manage competing priorities and deadlines in fast paced environment.

• 30% resource for global ITC activity as APAC focal points contact
• Work with external advisors to classify the export control numbers (ECCN’s, Control list numbers etc) for all products in line with US, EU, China and other trade regulations
• Manage the integrity of trade data in Asia Pacific Region;
• Identify and analyze global trends and requirements regarding compliance functions, programs, and risk management, develop metrics and indicators
• Drive scalable business solutions with Veolia Engineering, Commercial, Manufacturing, Operations, Logistics, Tax and other business teams to ensure compliance with Global Trade Regulations
• Assist Business Development, Contracts and Operations in identifying export related requirements in new business transactions
• Work with manufactures/vendors/taggers to set up the effective import / export processes to support operations
• Support Export Control Classification Number (ECCN) classifications for international shipments on a regular basis
• Develop framework for enhanced classification program utilized globally for determination of proper classification of materials and accurate payment of duties and taxes applicable

Requirements:

• Strong technical skills and experience with ECCN and HTS classification determination
• In-depth knowledge on import/export regulations and activities
• Prior experience with developing and implementing International Trade Compliance programs in MNC
• Experience with encryption technology and application to export controls preferred
• B.S or equivalent degree - Highly preferred
• Experience working with a Global Trade System such as SAP GTS preferred
• At least 3-5 years of Global Trade related experience preferred
• Experience with global trusted trader programs such as AEO, CSA, NEEC or other similar programs a plus
• Must be able to work with multiple cross functional and cross geographical teams

Benefits & Highlights:

• Work Style: Hybrid/Flex
• Location: Buona Vista
• Great employee benefit
• Weekly office lunches
• Reporting Line: Regulatory Manager, APAC

About the Role :-

Responsible for the daily operations of regulatory affairs and assures regulatory submissions meet local and regional compliance requirements. Staying abreast with regulatory compliance requirements and changes affecting company operations and products. Generates and manages submission documents for new products or changes to existing regulatory submissions.

• Writing, preparing, submitting regulatory documents for the South-East Asia (SEA) market (Arthrex distributor and subsidiary)
• Prioritising and organising multiples projects with competing priorities
• Participating in regulatory affairs planning for SEA markets
• Providing support in APAC level projects as and when needed
• Regularly maintaining and updating product registration and listing databases for the assigned country
• Implementing change control for already-approved products including regulatory submissions
• Keeping abreast with the latest regulatory updates within SEA relating to Arthrex products and ensuring Arthrex as a company is aware, ready and able to comply with the necessary changes
• Providing input to change management projects for global regulatory change assessments
• Participating and providing support in cross-functional collaboration on new product and country launches
• Assisting in activities relating to post market surveillance (i.e. Complaints, Performance Evaluation Reporting (PER), Adverse Event Reporting (AER), and/or liaising with Regulatory bodies in assigned countries)
• Participating in both internal and external quality system audits

Education and Experience:

• Degree qualified preferably in a Science or Engineering discipline
• Minimum 4-5 years direct RA experience within a medical device company
• Strong working knowledge of SEA medical device regulations and standards
• Knowledge of global regulations will be advantageous
• Excellent interpersonal skills, with proven ability to effectively communicate and form strong relationships with stakeholders across all levels
• Ability to work in fast paced environment and handle multiple tasks and requests
• Comprehension of technical, engineering or medical terminology, and/or ability to reference literature for understanding
• Technical skills in manufacturing or design relating to regulatory affairs will be advantageous

About Arthrex

Arthrex is a global medical device company and leader in new product development and medical education in Orthopaedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year. We are a privately held company with a family business culture committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.

• Sheet Metal Industry, Permanent Role

• Attractive Remuneration Package

• Good Benefits and Working Environment

• Well-Established Company

• Immediate Vacancy

Job Descriptions :

• Strengthen end-to-end supply chain function to achieve cost-down targets and diversify supply risks.
• Lead the Procurement team to manage an efficient flow of goods at competitive prices to ensure optimum production, while acting as the main point of contact between suppliers and the Company.
• Source, qualify, and negotiate with vendors to achieve optimum pricing for the materials/services required by the Company.
• Evaluate spending operations and actively seek for ways to improve and enhance the quality of products purchased and the timeliness of deliveries.
• Maintain relationships with suppliers while continually scouting for additional vendors.
• Conduct cost analyses and set benchmarks for improvement.
• Developing risk management procedures to mitigate losses in the event of product shortages.
• Draft or review commercial agreements with suppliers and negotiates for favourable terms for the Company.
• Monitor and update relevant departments regarding price fluctuations of goods and vendor pricing.
• Develop scalable business processes to drive better decisions in supply chain management, such as cost management, performance metrics, supplier selection, etc.
• Interface with cross-functional stakeholders, such as Engineering, Finance, Legal, Business and Factory Operations, Planning, and Logistics, to understand the business objectives, identify the gaps in the current process, and drive solutions.
• Define key supplier performance metrics, develop data collection and reporting processes, analyze the data, and drive improvement actions.
• Analyze cost and spending data and collaborate with internal teams to analyze risk and opportunity.
• Execute strategies driven by cost analysis, resource planning, and operational capacity.
• Ensure the very highest engineering standards and processes are implemented and are aligned to global specifications, considering business-specific requirements and needs.
  

Job Requirements :

• Relevant degree in Engineering/ Business/ Supply Chain Management
• At least 8 years of experience in Procurement and purchasing.
• Prior experience/exposure in Logistics is preferred.
  

HOW TO APPLY:

Interested applicants, please send in your resume by clicking "Apply Now".

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

All applications will be treated with the strictest confidence.

Chan Ngai Kuan, Elise

Dynamic Human Capital Pte Ltd

Registration number: R1548771

EA Licence No: 12C6253