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.

Please send your applications to careers@jnmedsys.com if the Apply Now button is not working for you

­­­­­­­­­­­­­­­­­­­­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.

Please send your applications to careers@jnmedsys.com if the Apply Now button is not working for you

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