Technical Supervisor

About Tianyi Medical (Thailand) Co., Ltd.

Tianyi Medical (Thailand) Co., Ltd. is a subsidiary of Tianyi Medical Group, a leading manufacturer of Class III medical devices with over 30 years of industry experience. The company specializes in the development and production of high-quality medical consumables, including blood purification products, infusion therapy products, and other medical device components.

To support global business expansion, Tianyi Medical has established its manufacturing facility in Thailand at Amata City Industrial Estate, Rayong. The facility operates under international quality standards, including ISO 13485, and serves customers across China and international markets. We are committed to delivering innovative, reliable, and safe medical products while continuously improving our manufacturing capabilities and quality management systems.

Position Summar

yThe Technical Supervisor is responsible for managing and maintaining products transitioning from R&D to commercial production. This role focuses on process development, product maintenance, lean manufacturing, quality improvement, and production support to ensure stable and efficient manufacturing operations. The position also plays a key role in analyzing market complaints, optimizing production processes, and coordinating cross-functional teams to improve product quality and manufacturing performance

.
Key Responsibiliti

es1. Product Transfer and Technical Manageme

• ntConvert R&D documentation, including BOMs, drawings, specifications, and process documents, into production-ready instructions for mass productio
• n.Maintain and control technical documentation for released product
• s.Design and optimize manufacturing process flows and parameter
• s.Plan, execute, and support process validation activities, including IQ, OQ, and P
• Q.Ensure production SOPs, work instructions, labels, and related process documents are complete, accurate, and up to dat

e.2. Lean Manufacturing and Process Improveme

• ntContinuously improve production processes to increase efficiency, reduce manufacturing costs, and enhance product quality and stabilit
• y.Identify and implement process optimization opportunities to support operational excellenc

e.3. Quality Improvement and Complaint Investigati

• onInvestigate and analyze market complaints related to raw materials and manufacturing processe
• s.Develop and implement corrective and preventive actions (CAPA) to eliminate root causes and prevent recurrenc
• e.Participate in product risk management activities and maintain process-related risk documentatio
• n.Drive continuous improvement initiatives to reduce product defects and improve process performanc

e.4. Production Support and Cross-Functional Coordinati

• onReview process documentation to ensure readiness and compliance with production requirement
• s.Troubleshoot and resolve manufacturing and product quality issue
• s.Collaborate closely with Production, Quality, and R&D teams to improve product design, manufacturability, efficiency, and cost performanc
• e.Participate in production meetings, follow up on action items, and ensure timely completion of assigned task

s.5. Team Leadersh

• ipLead and supervise technical team members in daily operation
• s.Support recruitment, training, coaching, performance evaluation, and skill development activitie
• s.Assign tasks and monitor team performance to ensure departmental objectives are achieve

d.6. Additional Responsibiliti

• esPerform other duties and special assignments as directed by managemen

t.
Qualificati

onsEducat

• ionBachelor's Degree or above in Engineering, Biomedical Engineering, Materials Engineering, Mechanical Engineering, or related fiel

ds.Experie

• nceMinimum 3 years of experience in Process Engineering, Manufacturing Engineering, or R&D within the Class III Medical Device indust
• ry.Hands-on experience with machining, extrusion, injection molding, welding, sterilization, or related manufacturing technologi
• es.Strong understanding of medical-grade polymer materials and their processing metho
• ds.Familiarity with ISO 13485 requirements and applicable medical device regulatio

ns.Technical Ski

• llsStrong knowledge of manufacturing processes, process validation, and product industrializati
• on.Proficient in technical documentation management, process development, and continuous improvement methodologi
• es.Competent in relevant engineering software and analysis too

ls.Competenc

• iesStrong learning agility and problem-solving capabili
• ty.Excellent analytical and critical-thinking skil
• ls.Innovative mindset with strong execution abili
• ty.Effective teamwork and communication skil
• ls.Ability to work professionally in English or Th

ai.
Autho

rityAdvisory Autho

• rityReview and provide recommendations on technical documentation and process optimizat

ion.Management Autho

• rityControl and approve process validation activities, drawings, BOMs, and process-related documentat

ion.Supervisory Autho

• rityMonitor compliance, accuracy, and effectiveness of manufacturing process documentat

ion.
Coordin

ationInt

• ernalCollaborate effectively with R&D, Production, Quality Assurance, and other internal departm

ents.Ext

• ernalCommunicate and coordinate with suppliers, business partners, contractors, and other external stakeholders as requ

ired.
Working Sc

• heduleWorking Hours: 08:00 AM – 05
• :00 PMWorking

Days:Week A: Monday –

FridayWeek B: Monday – Sa

turdayAlternate working schedule applies on a bi-weekly

• basis.Work Location: Amata City Industrial Estate, Rayong, Th

ailand

• Salary:To be discussed based on qualifications and exp