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 compliance with environmental health & safety (EHS) norms and cleanroom protocols.
- Enforce use of PPE, gowning procedures, and contamination control practices.

Reporting & Cost Control

- Track and report KPIs: production output, yield, rejection rate, downtime, and cost per unit.
- Manage production budget, control scrap/rework costs, and optimize resource utilization.
- Present daily/weekly production reports to senior management.

Required Qualifications

- Bachelor's Degree/Diploma in Electronics, Biomedical, Industrial, or Production Engineering.
- 5-8 years of experience in manufacturing, with at least 2 years in a production leadership role.
- Prior experience in medical device, pharmaceutical, or other highly regulated manufacturing environment is preferred.

Required Skills & Competencies

- Solid knowledge of ISO 13485, GMP, and cleanroom manufacturing practices.
- Hands-on experience with Lean Manufacturing or Kaizen methodologies.
- Proficiency in production planning tools/ERP systems (SAP, Oracle, etc.).
- Strong leadership, problem-solving, and cross-functional coordination skills.
- Excellent communication and documentation skills (SOPs, CAPA reports).

Pay: ₹550,000.00 - ₹750,000.00 per year

Application Question(s):

- Do you have experience with Lean Manufacturing or Kaizen methodologies
- Do you have knowledge of GMP, and cleanroom manufacturing practices
- Are you proficient in production planning tools/ERP systems (SAP, Oracle, etc.).
- Current CTC
- Expected CTC
- Do you have experience in medical device, pharmaceutical, or other highly regulated manufacturing environment

Work Location: In person

📌 Production Manager (India)
🏢 Gadgeon Medical Systems
📍 India