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.

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

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

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