Laboratory Technologist/Research Associate
Full-time
Job Responsibilities:
- Work with a team of Scientists and Engineers on product and application development
- Design and execute qPCR and digital PCR experiments independently
- Perform optimization/troubleshooting studies
- Documentation of all required information for projects according to ISO13485 requirements
- Support external/internal projects
- Proper housekeeping and cleanliness of laboratory
- Perform any other related duties as required
Job Requirements:
- Minimum Diploma in Biomedical Science, Life Science, Biotechnology or related discipline.
- Bachelor degree with at least 1-2 years relevant experience in molecular biology research is preferred
- Good laboratory knowledge and familiar with conducting PCR experiments
- Good planning and organizing skills
- Strong analytical and troubleshooting skills
- Good interpersonal skill
Please send your applications to careers@jnmedsys.com if the Apply Now button is not working for you
Technical Specialist
Full-time
Job Responsibilities:
- Responsible for activities in RUO and Diagnostic kit production, including maintenance/calibration of machine and tools according to ISO13485 requirements
- Responsible for qualification tests for the kits and company’s digital PCR instrument to ensure products meet the desired quality
- Conduct new product transfer (NPI), new line setup, and OEM projects with/from R&D and/or engineering team and eventually transfer to the manufacturing team
- Perform studies and qualification (validation) studies for new (improved) products and processes
- Optimize manufacturing process for efficiency, productivity, and quality
- Perform troubleshooting studies to provide database solution to product/process issues
- Lab management (general inventory management and purchase)
- All other tasks as assigned
Job Requirements:
- Academic Level: Bachelor Degree
- Field of Study: Life Science, Chemistry, or related discipline
- Experience: 2 years of work experiences. Experience in kit/reagent manufacturing is desirable
- Good laboratory knowledge and familiar with conducting PCR experiments
- Knowledge and experience working with Quality Management System (i.e. ISO 13485)
- Good planning and organizing skills
- Strong analytical and troubleshooting skills
- Good interpersonal skill
Please send your applications to careers@jnmedsys.com if the Apply Now button is not working for you
QA/RA Specialist (Manufacturing)
Full-time
Job Responsibilities:
- Ensure company’s ISO13485 Quality Management System are carried out effectively and maintained in accordance to released quality procedures, work instructions, documentation control system and applicable statutory and regulatory requirements.
- The scope shall cover quality related activities in the instrument, consumables and bio manufacturing
- In charge of the planning, coordination and execution of internal and external audits, work with all party to generate audit reports and audit closure.
- Conduct supplier assessment, qualification and evaluation of supplier’s performance.
- Responsible in conducting incoming, in-process and outgoing quality control and final product release to customer.
- Involve in Customer Feedback committee and follow up with relevant stakeholders in the investigation and closure of issues as according to company’s corrective and preventive action (CAPA) system.
- Responsible for company-wide calibration system and all related activities.
- Ensure risk management to product quality are effectively carried out and comply to SOP
- Lead in part non-conformance activities including conducting material review board meeting, supplier return handling, Supplier Corrective Action Request initiation, tracking and closure.
- Responsible for compiling, reviewing, submitting and following up regulatory submissions and marketing authorisation applications, where required
- Maintain records of regulatory submissions and communications to consultant (if any) and/or relevant regulatory authorities
Job Requirements:
- Academic Level: Diploma/Bachelor Degree holder or above;
- Field of Study: Mechanical, Electrical & Electronic Engineering, Bioengineering or Equivalent
- Experience: 3-5 years of experiences in manufacturing environment
- Familiar with ISO 13485 standards, local regulatory and compliance standards.
- Strong verbal and written communication skill, ability to work with cross functional department.
- Knowledge in SPC/six sigma/lean manufacturing and other improvement methodologies will be a plus.
Please send your applications to careers@jnmedsys.com if the Apply Now button is not working for you
Manufacturing Engineer
Full-time
Responsibilities:
- Develop and optimize manufacturing processes based on product line, including design, build, test, and implement improved manufacturing methods and equipment.
- Maintain bill of materials and process documentation accuracy, formulate part/process qualification plan, prepare report for approval.
- Conduct risk management, update process risk assessment matrix, control plan and technical files accordingly.
- Prepare engineering change orders and follow up with production implementation plan with complete change traceability.
- Manage, troubleshoot, maintain and repair of production tools and fixture to meet production operation target.
- Lead in production first pass yield activities; follow through with root cause investigation and improvements.
- Maintain company’s calibration system and activities based on standard operation procedure and work instruction.
- Provide product training to operator, technician and/or external personnel when required.
- Assist in the planning and execution of production build activities, including part purchases, inventory control and management.
- Manage contract manufacturer for on time delivery
- Lead/Support OEM projects
- Work closely with QA team to ensure manufacturing in compliance to certification standards and regulatory authorities.
- Ensure safety throughout manufacturing processes
- Communicate with suppliers on quality issues arising from non-conforming materials and follow up with corrective/preventive actions.
- Involved in quality management system activities such as internal/external audits, quality improvement projects.
- Provide support to R&D, Bio-chemistry and production team on troubleshooting and evaluation that involve manufacturing processes.
Requirements:
- Academic Level: Bachelor Degree holder or above;
- Field of Study: Mechanical, Electrical & Electronic Engineering or Equivalent
- Experience: 3-5 years of experiences in manufacturing environment
- Familiar with ISO 9001, 13485 standards, local regulatory and compliance standards.
- Familiar with production, QA/QC activities, materials management, logistics and warehousing operations.
- Knowledge in SPC/six sigma/lean manufacturing and other improvement methodologies will be a plus
Please send your applications to careers@jnmedsys.com if the Apply Now button is not working for you