Document 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

Production Tracking: Enter and update Device History Records (DHRs), batch travelers, and job orders in the ERP/MES system as parts progress through surface treatment stages.

QMS & Compliance Documentation: Assist quality and department engineers in organizing, filing, and archiving chemical lab logs, bath maintenance records, inspection reports, and calibration records.

Chemical & Supply Inventory Support: Track consumption levels of chemicals, abrasives, masking materials, and PPE; issue purchase requisitions to maintain optimal stock levels.

Scheduling & Inter-Department Coordination: Coordinate batch handoffs between machining, cleaning, surface treatment, secondary inspection, and cleanroom packaging teams.

Equipment & Maintenance Logistical Support: Maintain calibration and preventative maintenance schedules for tanks and other related equipment; interface with external vendors and maintenance technicians.

Department Reporting: Generate daily/weekly yield, throughput, and scrap reports for operations management.

Other duties relevant to the position as assigned by your supervisor.

Requirements

Required language(s): English, Bahasa Malaysia

Fresh graduate or at least 1 Year(s) of working experience in the related field is required for this position.

Required Skill(s): Computer literate - Microsoft Excel and Microsoft Words

Must be able to work in a team and independently

Good understanding of the requirements of ISO and/or FDA requirements will be an added advantage

Preferably executive specialized in Manufacturing/Production Operations, Document Control or equivalent.

Straits Orthopaedics (Mfg) Sdn Bhd ("Straits") is a situated at Batu Kawan. Straits is a medical devices manufacturer and our principal business is the production, cleaning and packaging of orthopaedics devices and accessories (trauma and reconstructive ) and wound care products. Mainly, all our product are exported to our customers in the United States of America, China, Japan, Europe etc. Straits is a company certified with ISO 13485 and ISO 9001. Our company is registered with US FDA and is required to comply with 21 CFR Part 820. Currently, we have approximately 1200 employees and due to our expansion, we are looking for qualified candidate to join our team as :

Straits Orthopaedics (Mfg) Sdn Bhd ("Straits") is a situated at Batu Kawan. Straits is a medical devices manufacturer and our principal business is the production, cleaning and packaging of orthopaedics devices and accessories (trauma and reconstructive ) and wound care products. Mainly, all our product are exported to our customers in the United States of America, China, Japan, Europe etc. Straits is a company certified with ISO 13485 and ISO 9001. Our company is registered with US FDA and is required to comply with 21 CFR Part 820. Currently, we have approximately 1200 employees and due to our expansion, we are looking for qualified candidate to join our team as :