13 Aug
|
Gadgeon Medical Systems
|
Angamaly
13 Aug
Gadgeon Medical Systems
Angamaly
Job Title: Assistant Manager/Manager – Production
Department: Production
Reports to: Senior Manager- Operations
Location: Angamaly, Kochi
Job Summary
The Assistant Manager/Manager is responsible for planning, coordinating, and controlling the manufacturing process to ensure the devices are produced safely, efficiently, and in full compliance with quality and regulatory standards (ISO 13485 and other applicable regulations). The role ensures production targets are met without compromising product quality, patient safety, or workplace safety.
Key Responsibilities
Production Planning & Execution
- Develop and execute daily, weekly, and monthly production schedules to meet demand and delivery timelines.
- Coordinate with Supply Chain, Quality and Maintenance teams to ensure availability of materials, manpower, and machinery.
- Monitor production output, cycle times, and line efficiency (OEE) and take corrective action on deviations.
Quality & Regulatory Compliance
- Ensure all production activities comply with ISO 13485, GMP, and other applicable medical device regulations.
- Enforce adherence to Standard Operating Procedures (SOPs) and batch manufacturing records (BMR).
- Support internal and external audits (ISO, notified body) and drive closure of CAPAs and NCs related to production.
- Maintain traceability and documentation as required for regulated medical device manufacturing.
Team Leadership
- Supervise, train, and mentor production team.
- Plan materials, manpower allocation and shift schedules to optimize productivity.
- Drive a culture of accountability, discipline, and continuous improvement on the shop floor.
Process Improvement
- Identify and implement Lean or Kaizen initiatives to reduce waste, cycle time, and cost.
- Drive process validation (IQ/OQ/PQ) activities in coordination with Quality and Engineering.
- Lead root cause analysis and implement corrective/preventive actions for production issues.
EHS & Cleanroom Compliance
- Ensure complian
📌 Production Manager (Angamaly)
🏢 Gadgeon Medical Systems
📍 Angamaly