Job Description

Technical Manager, Factory

Company:

Nihon Kohden Middle East (NKME)

Location:

Dubai, UAE

Department:

Factory / Operations

Reports to:

Factory Manager (or Head of Operations)

Direct Reports:

Process/Validation Engineers, Maintenance Engineers/Technicians; dotted-line to Warehouse/Logistics & QC/Lab teams

Employment:

Full-time

Role Purpose

Lead the site's

technical and cross-functional operations

--spanning

factory, logistics/warehouse, production & manufacturing, laboratory/QC, Quality Assurance (QA), and Regulatory Affairs (RA)

--to deliver safe, compliant, on-time, and cost-efficient output under

ISO 13485

and applicable regional regulations (MOHAP/UAE, SFDA, EU MDR, FDA as applicable).

Key Responsibilities1) Cross-functional site leadership

Own technical governance across

factory, logistics, production, lab, QA & RA

; set priorities, remove roadblocks, and ensure seamless handoffs (incoming materials ? manufacturing ? testing ? release ? dispatch). Chair daily/weekly tier meetings (SQDCP), escalate risks, and drive actions to closure.
2) Logistics & warehouse operations

Oversee inbound/outbound, customs/FZ compliance (JAFZA/DWC or equivalent), 3PL coordination, and

traceability/UDI

controls. Optimize layout, FEFO/lot control, cycle counts, and inventory accuracy; implement WMS/ERP transactions discipline. Ensure handling of

regulated/temperature-sensitive

materials where applicable; maintain shipping QA holds/release process with QA.
3) Production & manufacturing engineering

Design/transfer/sustain processes, line balancing, takt & work standards; author

SOP/WI

, PFMEA, control plans. Plan/execute

IQ/OQ/PQ

; maintain the Validation Master Plan and complete DQ/IQ/OQ/PQ files. Drive OEE, SMED, FPY, scrap reduction, and cost-to-serve improvements.
4) Laboratory / QC & testing

Lead QC/Lab operations (incoming, in-process, final),

metrology & calibration

, and method/equipment qualification. Ensure environmental monitoring/cleanroom discipline (as applicable) and timely

COA/COT

documentation. Define lab

TAT

targets; manage OOS/OOE investigations with QA.
5) Quality Assurance (QA)

Sustain

ISO 13485

QMS and risk management per

ISO 14971

; enforce

GDP/GMP

documentation. Ensure complete

DMR/DHR

, labeling/UDI compliance, and change control. Lead

deviations/NCRs/CAPA

, internal audits, supplier quality actions, and readiness for NB/regulatory audits.
6) Regulatory Affairs (RA)

Coordinate technical files, declarations, risk/clinical evidence links, and labeling for

MOHAP, SFDA, EU MDR, FDA

as relevant. Support registrations, vigilance/post-market surveillance, and UDI/EUDAMED or equivalent submissions. Ensure manufacturing/labeling changes remain in regulatory compliance; maintain market-specific variants.
7) EHS & statutory

Own machinery safety,

LOTO

, chemical handling, PPE, and statutory inspections; lead incident investigations and action closure.
8) Capex, digital & continuous improvement

Build business cases and manage Capex from URS/DQ ? FAT/SAT ? handover. Deploy

CMMS/EAM

, WMS, ERP/PLM, SPC/MSA dashboards; lead Kaizen/5S/VSM programs.
9) People leadership & vendors

Develop skills matrices and training for engineers/technicians, warehouse & lab teams (in coordination with function leads). Manage OEMs/service providers and key suppliers; negotiate SLAs and performance metrics.
KPIs

Inventory accuracy (cycle count):

?

98%

;

OTIF

(inbound/outbound): ?

98%

Critical equipment uptime:

?

95%

;

PM & calibration on-time:

?

98%

OEE improvement:

+5-10% YoY

on focus lines;

FPY:

?

98%

; scrap ? target

DHR completeness / lot traceability:

100%

; zero late DHR closures

CAPA/deviation closure:

within SLA;

zero

repeat major audit findings

Regulatory milestones:

submissions/variations on time; zero compliance slippages

Lab TAT:

meets target with ? target OOS rate

EHS:

zero recordable incidents; action closure ?

95%

on time

CI/Capex:

savings & ROI delivered per AOP
Qualifications & Experience

Bachelor's in Mechanical/Electrical/Industrial/Manufacturing Engineering (Master's preferred).

10+ years

in manufacturing/operations within

medical devices/diagnostics

or highly regulated industry, with proven

cross-functional exposure to logistics/warehouse, production, laboratory/QC, QA & RA

. Hands-on leadership of

process/equipment validation (IQ/OQ/PQ)

, tech transfer, and change control. Deep QMS knowledge (

ISO 13485, ISO 14971

) and working familiarity with

EU MDR / FDA 21 CFR 820 / MOHAP / SFDA

. Practical experience with

WMS/ERP/PLM

,

CMMS/EAM

, SPC/MSA, PFMEA/control plans, and Lean/Six Sigma (Green/Black Belt desirable). GCC/Dubai logistics compliance (customs, HS codes, free-zone processes) is a strong plus. Strong vendor/OEM management and cross-functional stakeholder leadership.
Core Competencies

Advanced troubleshooting & RCA (5-Why, Fishbone, FTA) and data-driven decision making Excellent documentation discipline and audit readiness Planning, prioritization, and change management in fast-moving environments Coaching, team development, and effective cross-functional influence
Job Type: Full-time

Pay: AED15,000.00 - AED25,000.00 per month

Application Question(s):

What is your knowledge of ISO 13485, GMP, and UAE/SFDA/MOHAP regulations? Do have experience in servicing, maintaining, or managing medical devices? What is your notice period in days? * What is your monthly salary expectation?