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

­­­­­­­­­­­­­­­­­­­­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

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