Career

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.
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Assistant Engineer (Manufacturing)

Full-time

 

Job Responsibilities:

  • Perform final test and qualification of digital PCR instruments based on standard protocols.
  • Troubleshoot, resolve and perform failure analysis on instruments including issues. pertaining to hardware, software and firmware.
  • Maintain proper documentation including failure logs.
  • Develop, maintain and update work assembly instructions, inventory, and bill of materials.
  • Improve and update test protocols including those pertaining to QC/QA.
  • Support deployment, installation, training and maintenance at customer locations.
  • Manage procurement process and work closely with vendors to ensure deliverables are met in a timely manner.
  • Support any engineering/development work
  • Support software verification/validation work

 

Job Requirements:

  • Diploma in Mechanical/Electrical/Electronics Engineering, Bioengineering or related field.
  • At least 3-5 years of experience in instrument hardware and software assembly and testing.
  • Experience in biomedical/life science manufacturing industry preferred.
  • Knowledge of genomic analysis particularly in PCR or digital PCR would be an advantage.
  • Knowledge of programming (C, C++ and Visual Basic) for firmware preferred.
  • Meticulous, attention to details, strong analytical, problem solving and communication skills.
  • Strong team player with the ability to work independently
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Please send your applications to careers@jnmedsys.com if the Apply Now button is not working for you