Operations Manager - Medical Device

Job Description

Key Responsibilities 1. Strategic Operations Management Lead and manage daily operations across departments: Purchase, Store, Production, QA, QC, and Export Coordination. Implement efficient production planning and scheduling to meet customer demands and reduce downtime. Optimize resource utilization and reduce wastage while maintaining cost-effective operations. 2. Data Analysis & Systems Implementation · Perform in-depth data analysis of production, quality, inventory, and compliance metrics. · Identify patterns, root causes of inefficiencies, and opportunities for improvement. 2. Quality & Compliance Ensure all processes align with ISO 13485:2016, CE, FDA, and country-specific regulatory requirements. Manage internal and external audits. Oversee document control, batch manufacturing records, change controls, CAPA, and product traceability systems. 3. Process Improvement & Efficiency Analyze operational KPIs and production metrics to identify bottlenecks and inefficiencies. Drive continuous improvement initiatives (Lean, Six Sigma, Kaizen) to enhance productivity and compliance. Implement and monitor Standard Operating Procedures (SOPs) across departments. 4. Cross-Functional Coordination Facilitate seamless communication and collaboration between departments. Support Sales and Export teams with production updates, dispatch timelines, and product availability. Coordinate with Engineering, and Maintenance for product and process improvements. 5. Procurement & Inventory Management Monitor raw material procurement and vendor performance. Ensure efficient stock control, storage practices, and timely replenishment of critical inventory. Maintain accurate purchase forecasts and align procurement with production schedules. 6. Reporting & Review Prepare and submit daily and weekly reports to top management on operations status, KPIs, compliance, and non-conformities. Lead operational review meetings and ensure action plans are followed and closed. 7. Team Leadership Supervise and mentor department heads and operational staff. Foster a culture of accountability, collaboration, and professional development. Set performance targets and conduct regular evaluations. Desired Skills & Qualifications Proven experience in operations management within medical device or pharmaceutical manufacturing. Strong knowledge of ISO 13485, CE marking, and regulatory compliance. Excellent analytical, problem-solving, and decision-making skills. Hands-on experience with ERP systems and production software. Strong interpersonal and communication skills for cross-departmental coordination. Ability to work under pressure and manage multiple priorities. Job Type: Full-time Pay: ₹30,000.00 - ₹45,000.00 per month Benefits: Provident Fund Schedule: Day shift Supplemental Pay: Yearly bonus Ability to commute/relocate: Vatva Gidc, Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Preferred) Experience: Operations: 3 years (Required) Work Location: In person