ISO/FDA-Ready Document Control Specialist

Straits Orthopaedics (Mfg) Sdn Bhd; Batu Kawan; On-site; MYR 36,000 - 48,000; Full time

Job summary

Straits Orthopaedics (Mfg) Sdn Bhd in Batu Kawan, Malaysia, seeks a Production Operations Support candidate to assist in tracking device history records, batch travelers, and job orders within our ERP/MES as parts move through surface treatment stages.

You will help organize quality and compliance documentation, monitor chemical inventories, coordinate inter-department handoffs, and maintain equipment maintenance logs, contributing to ISO 13485 and FDA 21 CFR 820 adherence.

Qualifications

• Fresh graduate or up to 1 year of related working experience.
• Proficient in English and Bahasa Malaysia.
• Good computer literacy with Excel and Word.
• Knowledge of ISO 13485 and FDA 21 CFR 820 is an advantage.

Responsibilities

• Production tracking: update DHRs, batch travelers, and job orders in ERP/MES as parts progress through surface treatment stages.
• QMS & compliance: assist in organizing, filing, and archiving lab logs, bath maintenance, inspection, and calibration records.
• Chemical & supply inventory: track chemical, abrasive, masking materials, and PPE usage; issue purchase requisitions to maintain stock.
• Scheduling & inter-department coordination: coordinate batch handoffs between machining, cleaning, surface treatment, inspection, and packaging teams.
• Equipment & maintenance logs: maintain calibration and preventive maintenance schedules for tanks and related equipment; interface with vendors/technicians.
• Department reporting: generate daily/weekly yield, throughput, and scrap reports for operations management.
• Other duties as assigned.

Skills

Teamwork

Independent Work

Attention to detail

Tools

Microsoft Excel

Microsoft Word

Job description

Straits Orthopaedics (Mfg) Sdn Bhd in Batu Kawan, Malaysia, seeks a Production Operations Support candidate to assist in tracking device history records, batch travelers, and job orders within our ERP/MES as parts move through surface treatment stages.

You will help organize quality and compliance documentation, monitor chemical inventories, coordinate inter-department handoffs, and maintain equipment maintenance logs, contributing to ISO 13485 and FDA 21 CFR 820 adherence.