The role is accountable for the safe, accurate, and fully compliant receipt, storage, handling, traceability, and internal distribution of raw materials, components, WIP, and finished medical devices — including sterile, temperature-sensitive, and hazardous materials — in line with ISO 13485, GMP, and GWP requirements. The Warehouse Manager directly supervises the Warehouse team, building a culture of quality, safety, and continuous improvement. The role will report to Supply Chain Manager.
Job responsibilities:
Warehouse Operations
- Plan, direct, and supervise all day-to-day warehouse activities — receiving, quarantine management, storage, picking, kitting, packing, and internal distribution — in full compliance with approved SOPs and regulatory requirements.
- Maintain physically segregated and visually controlled storage zones for all material categories; ensure environmental conditions (temperature, humidity) are monitored continuously and any excursion is documented and escalated promptly.
- Ensure all material transactions are recorded accurately in real time within the ERP/WMS (NetSuite/All Access); investigate and correct discrepancies without delay.
- Oversee complete and accurate shipping documentation for all inbound and outbound transfers; maintain warehouse equipment in safe working condition through scheduled preventive maintenance and calibration.
Receiving & Incoming Quality Control Interface
- Manage the complete inbound receiving process: verify deliveries against approved POs, apply quarantine controls immediately upon receipt, and coordinate with RAQA on IQC staging and release.
- Process approved materials to designated ERP/WMS locations promptly following RAQA release; manage the Return-to-Vendor (RTV) process for rejected materials with full traceability.
- Investigate and document all receiving discrepancies through the NC/CAPA system; submit receiving documentation to Finance & Admin within agreed cycle times.
Inventory Control & Accuracy
- Design and execute a risk-based cycle count program across all product categories and locations; investigate variances using formal RCA and implement corrective actions to prevent recurrence.
- Lead annual full physical inventory counts; manage the counting methodology, system freeze, reconciliation, and reporting to Supply Chain Manager and Finance.
- Enforce FIFO/FEFO disciplines across all warehouse zones and ERP/WMS pick transactions; ensure all materials are continuously and unambiguously identified with batch/lot numbers, expiry dates, and QC status from receipt to dispatch.
- Monitor inventory levels against safety stock thresholds; proactively communicate replenishment requirements to Procurement and Planning; elevate critical shortage risks with quantified production impact.
Sterile, Cold-Chain & Hazardous Materials Management
- Enforce validated storage and handling protocols for all sterile and temperature sensitive materials; respond to excursion events per defined procedures including quarantine, deviation documentation, and RAQA notification.
- Oversee receipt, labeling, segregation, storage, transfer, and disposal of all hazardous materials in compliance with OSHA, DENR, and SPI HAZMAT procedures; maintain current SDS/MSDS records and certified HAZMAT-trained personnel.
Compliance, QMS & Documentation
- Ensure all warehouse operations comply with ISO 13485, GDP/GWP, OSHA, DENR, and all applicable SOPs and quality plans; maintain all SOPs and work instructions in a current and controlled state.
- Manage all quality records — receiving, material movement, temperature monitoring, calibration, deviation, training, NCRs, CAPA — to be complete, legible, and retrievable on demand for the required retention period.
- Identify, contain, and elevate non-conformances through the SPI NC/CAPA system; lead RCA and provide evidence of corrective action completion to RAQA within defined timelines.
- Maintain warehouse operations in a permanently audit-ready state; serve as primary auditee for FDA, ISO 13485, MDSAP, and customer quality audits; conduct at minimum monthly self-inspection walkthroughs with documented findings tracked to closure.
- Initiate and manage Change Control Orders for all planned changes to warehouse layout, equipment, environment, or procedures before implementation.
Facility, Safety & Equipment
- Implement and sustain 5S across all warehouse areas; champion a zero-harm safety culture through daily toolbox talks, safety walkdowns, and immediate intervention on unsafe acts or conditions.
- Ensure all powered equipment is operated only by certified personnel; enforce LOTO procedures and PPE compliance as non-negotiable safety standards.
- Report all workplace incidents to Supply Chain Manager, EHS, and HR immediately; lead incident investigations using structured RCA and verify corrective actions before resuming the affected activity.
Process Improvement & Reporting
- Drive a continuous improvement culture using Lean/Kaizen methodologies; maintain a CI Register and recognize contributors; present improvement outcomes with beforeand-after metrics to the Supply Chain Manager.
- Maintain a live warehouse KPI dashboard (inventory accuracy, receiving cycle time, FIFO/FEFO compliance, order fulfillment accuracy, storage utilization, safety incident rate, training completion, CAPA closure rate) visible to the team.
- Prepare and submit daily exception reports, weekly operational summaries, and monthly KPI performance reports with trend analysis to the Supply Chain Manager.
Experience and Education:
- Bachelor's degree in Logistics, Supply Chain Management, Industrial Engineering, or related field. Post-graduate qualification in Quality Management, Operations, or Regulatory Affairs is an advantage.
- 5–7 years of progressive warehouse operations experience in a manufacturing environment, with at least 2–3 years in a supervisory or managerial role.
- Prior experience in a medical device, pharmaceutical, or life sciences environment operating under an ISO 13485-certified QMS is strongly preferred.
- Demonstrated working knowledge of ISO 13485:2016, GMP/GWP/GDP, and HAZMAT compliance requirements (OSHA HazCom/GHS or local equivalents); HAZMAT certification is an advantage.
- Proficiency in ERP/WMS systems (NetSuite, SAP, Oracle WMS, or equivalent) including inventory management, transaction processing, and operational reporting.
- Experience supporting or hosting regulatory inspections (FDA, ISO 13485, MDSAP, or equivalent) in a warehouse or materials management capacity is strongly preferred.
- Demonstrated experience implementing 5S, Lean, or Kaizen programs with measurable, documented outcomes.
- Strong verbal and written communication skills; able to produce clear operational reports, SOP documentation, and CAPA records, and communicate effectively with