#LifeAtDornier
Dornier MedTech’s global energy can be felt soaring across the hearts of our customers, the faces of our staff, and the minds of our industry peers all across the world. Dornier believes in fostering a culture of science, innovation and reliability in its people, products and services. These values serve as a compass that guides us towards meeting our everyday commitment to leading technology and improving life.
What’s it like to work at Dornier MedTech? It’s fun! We’re passionate about our products and our work.
Watch this video celebrating the launch of our Medilas H Solvo 35 Laser!
We are currently recruiting:
DORNIER FUTURE FORWARD
GRADUATE DEVELOPMENT PROGRAM
Future Forward is a program designed to accelerate learning and help new engineering graduates realize their potential by becoming an independent contributor over a 2-year timeline.
Build your capabilities using a practical and hands-on approach!
The Future Forward program is currently available in these 2 countries:
Quality Management & Regulatory Affairs Manager
This position has the responsibility to manage and maintain the Quality Management System of the company regionally and for business units, requiring the individual to coordinate with official authorities, either directly or indirectly via distributors, on regulatory requirements and issues concerning Dornier medical devices.
1.1 Quality Management
1.1.1 Implement and maintain the Company’s QMS in accordance to International Quality and Corporate Standards, and ensure compliance with legal or corporate specifications.
1.1.2 Ensure that corrective / preventive action plans are executed and completed in a timely manner, and the management is appraised of significant quality issues and progress.
1.1.3 Report any issues / complaints to the factory and support the factory to investigate and close out the issues in a timely manner.
1.1.4 Conduct periodic internal audits to ensure the QMS is effectively implemented and maintained.
1.1.5 Assume full responsibility as a Management Representative (including but not limited to participating in management reviews, promotion of awareness of quality and regulatory, continuous improvement of QMS and hosting 3rd party audits.)
1.1.6 Work closely with stakeholders to ensure that all Standard Operating Procedures (SOPs) are updated on a timely manner and are aligned with Global SOPs.
1.1.7 Work closely and communicate regularly with the factory Quality and Regulatory department to ensure no interruption of business due to Quality/Regulatory Affairs Issues.
1.1.8 Ensure that all controlled documents are maintained, revised and distributed according to Control of Document and Records procedure.
1.2 Regulatory Affairs
1.2.1 Coordinate all registration activities (including new product registrations and renewals) of Dornier products in Asia/Australia regions to ensure business continuity without any interruption of business
1.2.2 Monitor and initiate the extension for product registration in all sales regions.
1.2.3 Provide regulatory inputs to International Regulatory Affairs team for R&D projects and new business initiatives.
1.2.4 Support on enquiries and tenders that require certificates and/or documentation related to Regulatory Affairs regionally.
1.2.5 Produce periodic regulatory status updates to the management.
1.2.6 Ensure compliance with NEA, WSH and IMDA regulations for all Dornier products and employees.
1.3 Medical Device Reporting Officer (MDRO)
1.3.1 Handle incidents arising from all sales regions for the products and also support regional requirements based on product roadmap.
1.3.2 Coordinate the necessary measures and fulfil the obligation to report within the stipulated time frame to DMT’s MDRO and directly to all affected Asia/Australia authorities.
1.3.3 Support DMT’s MDRO by gathering information needed for the analysis and assessment of the reported incident.
2.1 Frequent travel regionally to manage the requirements of the role and establish good working relations with regulatory authorities and consultants.
1. Education/Qualifications
- Bachelors or Master’s Degree in Science/Engineering
- Working experience in Healthcare industry
- Internal auditor according to ISO13485:2016
2. Experience
- 7 years’ and above related experience
- About 3-4 years’ experience in a lead position managing the portfolio and a team
- In-depth knowledge of handling national and international certification organizations (notified body e.g. TUEV)
3. Aptitude
- Results-oriented with the ability to engage various stakeholders
- Able to work independently with minimum supervision
- Excellent communication and interpersonal skills with the ability to interact with all levels of staff.
- Highly motivated decision maker, assertive and able to work under pressure
- Effective time management and organizational skills
- English and Mandarin language skills.
4. Operational Skills
- Knowledge of Asia, Australia quality and regulatory requirements
- Proficient knowledge of ISO13485 and SS620 requirements
- Basic knowledge in CE or FDA certification requirements
- Proficient in MS Office
We regret that only shortlisted applicants will be notified.
Senior Specialist, Quality Management & Regulatory Affairs
This position is responsible for coordinating Quality and Regulatory activities with manufacturing sites for complaints resolution and closure and assisting in registration activities in Asia/Australia regions.
- Analyze quality concerns/complaints identified via product installations and matters arising from field service operations and follow-up with manufacturing site until closure and resolution
- Report any issues/complaints to manufacturing site and inform Medical Device Reporting Officer (MDRO) on any reportable incidents.
- Compile documents for new registrations and renewal of licenses for Asia/Australia market.
- Conduct periodic assessments of adherence (internal audits) of all departments to ensure that they comply with current regulations. If any NC, to advise and support until closure and implementation.
- Support supplier audits in Asia/Australia regions.
- Support on enquires and tenders that require certificates and/or documentation related to Regulatory Affairs regionally. Establish and compile such documents.
- Gather regulatory intelligence and inform QM/RA Manager on upcoming changes in standards and regulations.
- Responsible for the control of documents and notify all employees on the release of new or updated documents.
- Obtain new and maintain current licenses with the National Environment Agency (NEA) for all Dornier medical devices, users and employees, including compilation and submission of all NEA licenses and renewals and attendance at NEA and regulatory briefings and seminars.
Education/Qualifications
- Bachelor’s degree in life sciences, engineering, biomedical or equivalent. Applicants with relevant work experience but without degree are also welcome to apply.
Experience
- Minimum 3 years QA/RA experience within medical device industry.
- Strong knowledge of regional regulatory pathways and requirements, e.g. Submissions, Technical Files
- In-depth Knowledge of handling national and international certification organizations (e.g. TÜV)
Aptitude
- Adaptable to fast-paced, results-oriented work environment
- Able to work independently with minimum supervision
- Highly motivated, decision maker, assertive and able to work under pressure
- Excellent interpersonal skills – i.e. ability to work flexibly across a multi-disciplinary team in jointly achieving given goals; good judgement and analytical skills
- Must be able to manage multiple tasks and perform with accuracy and highly attentive to details – strong team player who is willing to take on and support other activities outside core expertise as required
- Effective time management and organizational skills
- English and Mandarin language skills
Operational Skills
- Knowledge of ISO13485:2016 (Internal auditor) and SS620 requirements
- Knowledge in HSA and NEA regulations
- Proficient in Microsoft Office
We regret that only shortlisted applicants will be notified.
Service Manager
The Service Manager is involved in organizing and executing initiatives that will grow the Service business and improve the key performance metrics of the Service organization.
- Manage and provide leadership to the service team
- Grow the Service business
- Implement and optimize business processes
- Engage and upskill service teams of regional partners
- People development
- Ad-hoc projects
Education/Qualifications
- Degree/Diploma in Biomedical or Electrical/ Electronic Engineering
Experience
- Minimum 4 years’ relevant experience in leading a team servicing high-tech medical equipment
- Executing initiatives resulting in direct business growth
- Executing initiatives leading to improved metrics/customer satisfaction
Aptitude
- Able to work independently with minimal supervision
- Good communication and interpersonal skills with the ability to interact with all levels of staff
Operational Skills
- Customer centric
- Critical thinking
- Measure and improve key service metrics
- Key stakeholder management
- Troubleshooting skills
- Knowledge of Shock wave, ultrasound and x-ray is an advantage.
We regret that only shortlisted applicants will be notified.
Senior Accountant (Advanced MedTech)
Support and assist the Group Consolidation team in all financial and management reporting on group consolidation accounts, including presentation of reports and statistics reflecting earnings, profit, cash balances and other financial results. Support in coordinating the budgeting and forecasting processes with SBUs and assist in the year-end statutory audit process. Assist and work closely with the accounting department to help maintain the accounting records and support the financial operations of Advanced MedTech Group of companies.
1.1 Coordinate Group consolidation and reporting of financial and management reporting as well as manage the year-end statutory audit process with external auditors. Work closely with the consolidation and reporting team on compliance and on the implementation of International Financial Reporting Standards and support the budgeting and forecasting processes.
1.2 Group Consolidation & legal entity accounting
1.2.1. Liaise with SBUs to ensure timely submission of monthly Cognos data and Management Information System (MIS) reporting to ensure no delay in group consolidation of financial and management reporting.
1.2.2. Handle Group consolidation for financial and management reporting and ensure accurate and timely submission of group reports to the Parent Company.
1.2.3. Handle legal entity full set of accounts and accounting-related activities including liaising with tax agents to provide information for corporate income tax return preparation as well as preparation of quarterly GST returns and filing.
1.3 Cognos Controller Reporting
1.3.1 Coordinate and verify monthly submission of Cognos reporting data and MIS reports from all SBUs to facilitate monthly management review process.
1.4 Budgeting and Forecasting process
1.4.1. Ensure that SBUs submit the budget and forecast reports on time to facilitate the review processes.
1.4.2. Involve in the preparation and consolidation of group budgets and forecasts including Profit & Loss, Balance Sheet, Cash Flow and variance analysis.
1.5 Year-end Statutory Audit
1.5.1 Coordinate and manage year-end statutory audit and work closely with SBUs to ensure timely completion and submission of audited financials and report schedules within the Parent Company’s stipulated deadline.
1.6 Support in pipeline and business review
1.6.1. Participate actively in regular sales pipeline and business reviews with sales and operating business units
2.1 Support the implementation of improvement projects in accounting, reporting and finance related activities.
2.1.1 Evaluate and implement improvement in operational processes
2.1.2. Support in Ad-hoc projects
Assists the Group Finance team in ad-hoc projects and assignments (e.g. annual corporate insurance renewal and treasury support on banking related matters)
- Degree in Accountancy
- Minimum two years of consolidation experience at Group level
- At least three years of working experience in finance, accounting and reporting functions.
- Good knowledge of International Accounting Standards and proficient in Excel
- Able to work across all levels of employees
- Fluent in English, both oral and written
We regret that only shortlisted applicants will be notified.