Total 13 job vacancies by Abiores Pte. Ltd.

Job Responsibilities:

1. Assist in the development of marketing brochures and materials that effectively communicate our brand's message to our target audience.

2. Provide creative ideas and strategies for e-commerce platforms, including company websites, Tik-tok etc., ensuring engaging and delivering consistent content to increase brands visibility and sales.

3. Support and handle e-commerce orders as required, including packing, shipping, and delivery of stocks, ensuring timely and accurate delivery of products according to orders.

4. Active follow-up on sales and orders, engaging and maintaining strong relationships with our clients.

5. Fluent in both Chinese and English is essential for this role to communicate effectively with our diverse client base and stakeholders.

6. Knowledge of Adobe Illustrator or Photoshop is required to create visually appealing marketing materials and online content.

7. Organize and support tradeshows, representing CorDx at events to promote our products and services to wider audience.

8. The role offers the opportunity to travel, enabling you to engage directly with clients and partners and exploring new markets.

Job Qualifications:

1. Bachelor's degree in Marketing, Communications, or relevant fields.

2. Proven experience as a Marketing Executive or similar role.

3. Strong understanding of digital marketing platforms and content creation.

4. Excellent organizational skills and attention to detail.

5. Ability to work independently and in a team environment.

6. Creative mindset with basic graphic design skills.

7. Willingness to travel as required by the job.

Job Description:

- Develop and implement regulatory strategies to secure product approvals more quickly than competitors.

- Lead complex decision-making processes among stakeholders and senior leadership in a dynamic regulatory environment.

- Provide expert advice on regulatory strategy, Health Authority engagement, and submission activities for the IVD product lines.

- Collaborate with internal teams, including R&D, Quality Assurance, and Clinical Affairs, to ensure that regulatory requirements are incorporated into product development and lifecycle management.

- Represent regulatory affairs in global business and strategic leadership meetings while supporting the IVD sectors.

- Mentor and guide regulatory staff and teams across various product modalities.

- Set and establish departmental goals and objectives.

Job Requirements:

- A Master’s degree in a Science or Technology field.
- Previous experience in the Medical Device or Healthcare sector.

- At least ten (10) years of experience in Regulatory Affairs within the medical device industry.
- Proven ability to lead and develop teams across multiple countries
- Excellent verbal and written communication skills in English.
- Extensive regulatory experience across multiple APAC countries.
- Strong attention to detail and the ability to navigate a matrixed environment.

Job Responsibilities

1. Product registration: including preparation of registration dossier, design of performance evaluation study and manage execution and communication with CRO (clinical research organization).
2. Be the subject matter expert on medical devices laws and regulations for product registration in company’s regions of interest.
3. Interface the communication with regulatory agencies, e.g. Health Science Authority, Medical Device Authority, Food and Drug Administration, track the progress of product registration, and resolve problems raised by reviewers during the review process.
4. Involve in the process of product testing, clinical verification, data collection and relevant tracking.
5. Submit to agencies scientific special projects on behalf of the company.
6. Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies.
7. Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
8. Any other ad-hoc duties or projects as required by the management team.

Job Qualifications:

1. A bachelor's degree in Life Sciences, Pharmacy, or a related field with at least 2 years of experience.
2. Familiar with ISO13485 quality management system, solid medical device quality management qualifications, including but not limited to Class B, C and D medical devices.
3. Expert in medical device product registration laws and regulations, able to independently draft registration dossier.
4. You shall have complete registration experience of Class B, C and D medical devices.
5. Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.
6. Familiar with IVD product development and commercialization life cycle.
7. Systematically project management, good planning, execution and timely communication. Good presentation skills.
8. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
9. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.

Job Responsibilities:

• Build, develop, and maintain strong customer relationships with business partners, including academic and public institutions, hospitals, major clinic chains, pharmacies, dealers, and agents.
• Generate repeated sales and cultivate long-term, value-driven collaborations.
• Provide market feedback and implement relevant sales strategies.
• Establish and maintain a positive company image and customer relationships, including developing key customers.
• Exhibit excellent market sensitivity and adaptability to market changes.
• Regularly summarize and analyze sales results, submitting relevant data and reports.
• Manage and respond to queries from potential customers and follow up on leads and referrals.
• Collaborate closely with the Sales team on sales plans to achieve or exceed sales targets through value creation selling activities.
• Stay updated with product knowledge and informed about competitors’ products.
• Provide accurate forecasts, pipeline data, and market intelligence on competitors to management.
• Maintain an up-to-date customer list with contact details.
• Lead and manage the sales team's KPIs, ensuring timely achievement of targets.
• Collaborate with cross-functional leadership teams to align business development goals with overall organizational objectives.
• Perform any other ad-hoc duties or projects within the sales and marketing function as required by the management team.

Qualifications:

• Strong network in the medical device and pharmaceutical business.
• A Bachelor Degree with at least 2 years of relevant experience (others are welcome to apply).
• Familiarity with in vitro diagnostic products such as lateral flow immunoassay, PCR, and Immunoassay.
• Understanding of IVD product development and commercialization lifecycle.
• Strong project management skills, including planning, execution, and timely communication.
• Excellent presentation skills.
• Preferred majors: biology, medicine, laboratory science, immunology, pharmacy, or quality engineering.
• Enthusiastic, proactive, and down-to-earth work attitude with strong communication and execution abilities.
• Results-driven and a team player.
• Meticulous with a strong sense of responsibility, able to handle stress and tight schedules.

Job Descriptions:

1. In charge of the preparation of reagents, calibration materials, and quality control products, strictly follow SOP, keep all records in the receipt, review, and use of raw and supplementary materials, monitor the stock condition and work with procurement team to replenish accordingly.

2. Responsible for the collection and bookkeeping of raw materials, auxiliary materials, packaging materials, etc. for production.

3. Responsible for filling in production logbook to ensure that the data is true, complete and accurate.

4. Ensure production equipment, facilities and production environment can meet production process and regulatory requirements.

5. Ensure employee working environment and quality in strict accordance with the system and regulatory requirements.

6. Strictly comply with laboratory-related operation and quality management requirements.

7. Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.

8. Any other ad-hoc duties or projects as required by the management team.

Job Descriptions:

1. Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred.

2. A bachelor's degree. Fresh graduates are welcome to apply.

3. Experience in IVD, controlled environment production, quality system, R&D and etc.

4. Expertise in the operation and maintenance of lab instruments and data systems.

5. Understand the relevant requirements of the production quality system for in vitro diagnostic products.

6. Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.

7. Familiar with IVD product development and commercialization life cycle.

8. Systematically project management, good planning, execution and timely communication. Good presentation skills.

9. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.

10. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.

Job Descriptions

• Support business development through the preparation of presentations, quotations, tenders, contracts, and agreements.
• Generate and present reports related to sales, pricing, promotions, inventory, and operations.
• Act as the main point of contact for customers, ensuring all correspondences and activities are documented and stored.
• Ensure SOPs are adhered to, supporting regular audits and checks by internal departments and external auditors.
• Liaise with internal Legal and Finance departments to ensure all contracts and agreements comply with rules and regulations.
• Maintain all documents (hard-copy, soft-copy, and online) related to Sales Operations and administration.
• Handle mail and phone calls.
• Manage office refreshments, stationery, pantry supplies, office items, etc.
• Any other ad hoc work duties.

Requirements

• Bachelor’s Degree in administration or a related field.
• Candidates with no prior experience are also welcome to apply.
• Proficiency in Microsoft applications such as Excel, Word, and Outlook is a must.
• Excellent communication skills, both verbal and written.
• Meticulous with good analytical and problem-solving skills.
• Jational and time management skills to meet deadlines.

Job Responsibilities

1. Product registration: including preparation of registration dossier, design of performance evaluation study and manage execution and communication with CRO (clinical research organization).
2. Be the subject matter expert on medical devices laws and regulations for product registration in company’s regions of interest.
3. Interface the communication with regulatory agencies, e.g. Health Science Authority, Medical Device Authority, Food and Drug Administration, track the progress of product registration, and resolve problems raised by reviewers during the review process.
4. Involve in the process of product testing, clinical verification, data collection and relevant tracking.
5. Submit to agencies scientific special projects on behalf of the company.
6. Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies.
7. Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
8. Any other ad-hoc duties or projects as required by the management team.

Job Qualifications:

1. A bachelor's degree in in Life Sciences, Pharmacy, or a related field
2. Familiar with ISO13485 quality management system, solid medical device quality management qualifications, including but not limited to Class B, C and D medical devices.
3. Expert in medical device product registration laws and regulations, able to independently draft registration dossier.
4. You shall have complete registration experience of Class B, C and D medical devices.
5. Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.
6. Familiar with IVD product development and commercialization life cycle.
7. Systematically project management, good planning, execution and timely communication. Good presentation skills.
8. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
9. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.

Assistant Manager / Manager, R&D

About CorDx:

CorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,000 employees across the world, serving millions of users in over 100 countries.

CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world.

With nearly two decades of IVD experience, CorDx is a leader in IVD research and development, manufacturing, and supply chain. Our proprietary line of rapid diagnostic products is recognized by families and medical professionals for reliability, affordability, and rapid results.

CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Job Responsibilities

• Responsible for new product development, experiment and optimize buffer composition, reagents and recipes;
• Responsible for the testing and experiments of key raw materials, able to independently plan, analyze and summarize experimental data;
• Responsible for solving technical problems encountered during the research, development & production process;
• Strictly comply with laboratory-related operation and quality management requirements
• Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
• Any other ad-hoc duties or projects as required by the management team.

Qualifications:

• Experience in IVD, clean environment production, quality system, R&D and etc;
• Expertise in the operation and maintenance of lab instruments and data systems;
• Understand the relevant requirements of the production quality system for in vitro diagnostic products;
• A bachelor's degree with 7 years of relevant experience, a master's degree with 3 years of relevant experience, or a doctorate degree with at least 1 year of relevant experience. Others are welcome to apply.
• Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc;
• Familiar with IVD product development and commercialization life cycle;
• Systematical project management, good planning, execution and timely communication. Good presentation skills.
• Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred;
• Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player;
• Meticulous and strong sense of responsibility; able to handle stress and tight schedule;

How to Apply:

• Please send a comprehensive resume, a cover letter (If applicable), along with your current and expected salary and send to foongying@cordx.com or apply @ My Careerfuture.
• We regret that only shortlisted candidates will be contacted

Assistant Manager / Manager, Regulatory Affairs

About CorDx:

CorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,000 employees across the world, serving millions of users in over 100 countries.

CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world.

With nearly two decades of IVD experience, CorDx is a leader in IVD research and development, manufacturing, and supply chain. Our proprietary line of rapid diagnostic products is recognized by families and medical professionals for reliability, affordability, and rapid results.

CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Job Responsibilities

• Lead product registration: including preparation of registration dossier, design of clinical trial and manage execution and communication with CRO (clinical research organization);
• Be the expert on laws and regulations for product registration in company’s regions of interest;
• Interface the communication with regulatory agencies, e.g. Food and Drug Administration, track the progress of product registration, and resolve problems raised by experts during the review process;
• Lead the process of product testing, clinical verification, data collection and relevant tracking;
• Submit to agencies scientific special projects on behalf of the company;
• Guide the company’s audit review from regulatory bodies e.g. the Food and Drug Administration, lead the company's internal review, and participate in the operation and maintenance of the company's various quality management system.
• Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies;
• Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
• Any other ad-hoc duties or projects as required by the management team.

Qualifications:

• Familiar with ISO13485 quality management system, solid medical device quality management qualifications, including but not limited to Class II and III medical devices;
• Expert in medical device product registration laws and regulations, able to independently draft registration dossier;
• You shall have complete registration experience of Class II and Class III medical devices;
• A bachelor's degree with 7 years of relevant experience, a master's degree with 3 years of relevant experience, or a doctorate degree with at least 1 year of relevant experience. Others are welcome to apply.
• Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc;
• Familiar with IVD product development and commercialization life cycle;
• Systematical project management, good planning, execution and timely communication. Good presentation skills.
• Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred;
• Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player;
• Meticulous and strong sense of responsibility; able to handle stress and tight schedule;

How to Apply:

• Please send a comprehensive resume, a cover letter (If applicable), along with your current and expected salary and send to foongying@cordx.com or apply @ My Careerfuture.
• We regret that only shortlisted candidates will be contacted

Sales Executive

About CorDx:

CorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,000 employees across the world, serving millions of users in over 100 countries.

CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world.

With nearly two decades of IVD experience, CorDx is a leader in IVD research and development, manufacturing, and supply chain. Our proprietary line of rapid diagnostic products is recognized by families and medical professionals for reliability, affordability, and rapid results.

CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Job Responsibilities

• Build, develop and maintain good and close customer relationship with our business partners, especially the market key influencers such as academic and public institutions, hospitals, major clinic chains, pharmacies, dealers, agents, etc. with the aim to generate repeated sales & cultivating long-term, value-driven collaborations
• Responsible for providing market feedback information and implementing the company's relevant sales strategies;
• Responsible for establishing good customer relationships (including developing key customers) and maintaining good company image;
• Excellent market sensitivity and able to quickly adapt to market changes;
• Regularly summarize and analyze sales results, and submit relevant data, reports, etc.
• Manage and generate response to queries from potential customers and follow-up on leads and referrals.
• Work closely with the Sales team on sales plans to achieve or exceed the sales targets set by the Management through value creation selling activities.
• Keep updated with product knowledge and stay informed of competitors’ products.
• Provide accurate forecasts and pipeline data as well as market intelligence on competitors to the Management.
• Develop and maintain an up-to-date customer list with contact details.
• Lead and manage the sales team's KPIs, ensuring timely achievement of targets.
• Collaborate with cross-functional leadership teams to synchronize business development goals with overall organizational objectives.
• Any other ad-hoc duties or projects within the sales and marketing function as required by the management team.

Qualifications:

• Strong network in medical device and pharmaceutical business.
• A diploma with 2 years of relevant experience. Others are welcome to apply.
• Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc;
• Familiar with IVD product development and commercialization life cycle;
• Systematical project management, good planning, execution and timely communication. Good presentation skills.
• Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred;
• Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player;
• Meticulous and strong sense of responsibility; able to handle stress and tight schedule;

How to Apply:

• Please send a comprehensive resume, a cover letter (If applicable), along with your current and expected salary and send to foongying@cordx.com or apply @ My Careerfuture.
• We regret that only shortlisted candidates will be contacted

Assistant Manager / Manager, Production

About CorDx:

CorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,000 employees across the world, serving millions of users in over 100 countries.

CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world.

With nearly two decades of IVD experience, CorDx is a leader in IVD research and development, manufacturing, and supply chain. Our proprietary line of rapid diagnostic products is recognized by families and medical professionals for reliability, affordability, and rapid results.

CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Job Responsibilities

• In charge of the preparation of reagents, calibration materials, and quality control products, strictly follow SOP, keep all records in the receipt, review, and use of raw and supplementary materials, monitor the stock condition and work with procurement team to replenish accordingly;
• Responsible for the collection and bookkeeping of raw materials, auxiliary materials, packaging materials, etc. for production;
• Responsible for filling in production logbook to ensure that the data is true, complete and accurate;
• Ensure production equipment, facilities and production environment can meet production process and regulatory requirements;
• Ensure employee working environment and quality in strict accordance with the system and regulatory requirements.
• Strictly comply with laboratory-related operation and quality management requirements
• Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
• Any other ad-hoc duties or projects as required by the management team.

Qualifications:

• Experience in IVD, clean environment production, quality system, R&D and etc;
• Expertise in the operation and maintenance of lab instruments and data systems;
• Understand the relevant requirements of the production quality system for in vitro diagnostic products;
• A bachelor's degree with 3 years of relevant experience, a master's degree with 1 years of relevant experience. Others are welcome to apply.
• Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc;
• Familiar with IVD product development and commercialization life cycle;
• Systematical project management, good planning, execution and timely communication. Good presentation skills.
• Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred;
• Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player;
• Meticulous and strong sense of responsibility; able to handle stress and tight schedule;

How to Apply:

• Please send a comprehensive resume, a cover letter (if applicable), along with your current and expected salary and send to foongying@cordx.com or apply @ My Careerfuture.
• We regret that only shortlisted candidates will be contacted

Business Development Manager

About CorDx:

CorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,000 employees across the world, serving millions of users in over 100 countries.

CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world.

With nearly two decades of IVD experience, CorDx is a leader in IVD research and development, manufacturing, and supply chain. Our proprietary line of rapid diagnostic products is recognized by families and medical professionals for reliability, affordability, and rapid results.

CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Job Responsibilities

• Build, develop and maintain good and close customer relationship with our business partners, especially the market key influencers such as academic and public institutions, hospitals, major clinic chains, pharmacies, dealers, agents, etc. with the aim to generate repeated sales & cultivating long-term, value-driven collaborations
• Responsible for providing market feedback information and implementing the company's relevant sales strategies;
• Responsible for establishing good customer relationships (including developing key customers) and maintaining good company image;
• Excellent market sensitivity and able to quickly adapt to market changes;
• Regularly summarize and analyze sales results, and submit relevant data, reports, etc.
• Manage and generate response to queries from potential customers and follow-up on leads and referrals.
• Work closely with the Sales team on sales plans to achieve or exceed the sales targets set by the Management through value creation selling activities.
• Keep updated with product knowledge and stay informed of competitors’ products.
• Provide accurate forecasts and pipeline data as well as market intelligence on competitors to the Management.
• Develop and maintain an up-to-date customer list with contact details.
• Lead and manage the sales team's KPIs, ensuring timely achievement of targets.
• Collaborate with cross-functional leadership teams to synchronize business development goals with overall organizational objectives.
• Any other ad-hoc duties or projects within the sales and marketing function as required by the management team.

Qualifications:

• Strong network in medical device and pharmaceutical business.
• A bachelor's degree with 7 years of relevant experience, a master's degree with 3 years of relevant experience, or a doctorate degree with at least 1 year of relevant experience. Others are welcome to apply.
• Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc;
• Familiar with IVD product development and commercialization life cycle;
• Systematical project management, good planning, execution and timely communication. Good presentation skills.
• Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred;
• Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player;
• Meticulous and strong sense of responsibility; able to handle stress and tight schedule;

How to Apply:

• Please send a comprehensive resume, a cover letter (If applicable), along with your current and expected salary and send to foongying@cordx.com or apply @ My Careerfuture.
• We regret that only shortlisted candidates will be contacted

Assistant Manager / Manager, Quality Assurance

About CorDx:

CorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,000 employees across the world, serving millions of users in over 100 countries.

CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world.

With nearly two decades of IVD experience, CorDx is a leader in IVD research and development, manufacturing, and supply chain. Our proprietary line of rapid diagnostic products is recognized by families and medical professionals for reliability, affordability, and rapid results.

CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Job Responsibilities

• Implement, manage and constantly improve the company’s quality management system, including but not limited to the IVD products and equipment;
• Regularly perform internal audits, compile audit reports, problem analysis reports, improvement proposals, and monitor the rectification plan and its implementation;
• Lead and Participate in the internal audits and management reviews of the company's quality system as key member of company's quality department;
• Manage the system and documents of company’s quality management system, including but not limited to the IVD products and equipment;
• Be specifically responsible for the IVD equipment quality management system;
• Statistical analysis of IVD equipment quality data, and draft reports and corrective and preventive measures;
• Update quality standards, laws and regulations and publish company quality policy;
• Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies;
• Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
• Any other ad-hoc duties or projects as required by the management team.

Qualifications:

• Quality system related training and internal auditor training;
• Familiar with ISO9000 & ISO13485 quality management system and certification work, experience with successful case(s) will be preferred;
• Familiar with GMP and medical device industry standards and specifications;
• Strong quality management system knowledge and capabilities;
• A bachelor's degree with 7 years of relevant experience, a master's degree with 3 years of relevant experience, or a doctorate degree with at least 1 year of relevant experience. Others are welcome to apply.
• Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc;
• Familiar with IVD product development and commercialization life cycle;
• Systematical project management, good planning, execution and timely communication. Good presentation skills.
• Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred;
• Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player;
• Meticulous and strong sense of responsibility; able to handle stress and tight schedule;

How to Apply:

• Please send a comprehensive resume, a cover letter (if applicable), along with your current and expected salary to foongying@cordx.com or click to submit here @ My careerfuture.
• We regret that only shortlisted candidates will be contacted