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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­­­­­­­­­­­­­­­­­­­­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
Apply nowApply now

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

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