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QA/RA Specialist (Manufacturing)

Full-time

Job Responsibilities:

  • Ensure the company’s ISO13485 Quality Management System is carried out effectively and maintained in accordance with 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 biomanufacturing
  • Management of document control system
  • In charge of the planning, coordination, and execution of internal and external audits, work with all parties 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 customers.
  • Involve in Customer Feedback committee and follow up with relevant stakeholders in the investigation and closure of issues according to the 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 with 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 authorization 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.
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­­­­­­­­­­­­­­­­­­­­Medical Technologist

Full-time

Responsibilities:

  • Perform clinical testing of samples for a molecular diagnostics laboratory.
  • Perform all test procedures in accordance with laboratory protocols.
  • Ensure the release of accurate and timely results to clients and manage telephone enquiries pertaining to test results.
  • Perform, record, and interpret quality control results, taking necessary corrective action as required.
  • Assist to ensure all equipment in the laboratory meets safety and performance standards.
  • Abide by laboratory safety requirements and procedures.
  • General housekeeping to maintain a safe and clean working environment in the clinical laboratory.
  • Assist to draft and maintain laboratory standard operating procedures (SOP) and risk assessment (RA) documentations.
  • Participate in internal and external quality assurance programs, and proficiency testing.
  • Inventory management of laboratory supplies.
  • Perform shift duties as required.

Requirements:

  • Degree in Biomedical Science, Biotechnology, Life Science, or related discipline.
  • Minimum one year of experience in a clinical laboratory setting.
  • Competent in molecular techniques such as PCR, qPCR. Experience with NGS and digital PCR would be an added advantage.
  • Experience in regulatory and laboratory accreditation (i.e., CAP, ISO 15189) would be an added advantage.
  • Good laboratory and strong analytical skills.
  • Meticulous, well-organized and thrive under pressure.
  • Highly motivated, independent, and willing to learn.
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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
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