Job Title: Production / Operations Manager – Medical Devices (ISO 13485)
Company: MAJiK Medical Solutions Pvt. Ltd. • Full-time • Hyderabad, Telangana, India (On-site)
Company Overview
MAJiK Medical Solutions is an ISO13485 certified company that provides high-quality custom medical device manufacturing solutions to the global medical device industry. At MAJiK Medical we assemble finished devices, manufacture reinforced medical tubing (braided/coiled), injection/insert mold hubs/handles, manufacture braided/spiral wire for various applications in the medical device industry.
Specialized in manufacturing complex medical catheters, MAJiK operates in > 10000 SFT ISO Class 7/8 cleanroom manufacturing space in India, MAJiK Medical provides high quality and economical solutions for medical tubing needs.
About the Role
Own the end-to-end production and operations function to ensure safe, compliant, efficient, and on-time manufacturing of medical devices, in line with ISO 13485, regulatory, and quality standards.
Key Responsibilities
Production & Operations Management
Plan, organize, and monitor daily production activities to meet output, quality, and delivery targets
Ensure optimal utilization of manpower, machines, and materials
Drive continuous improvement to improve productivity, cycle time, and cost efficiency
Quality & ISO 13485 Compliance
Ensure strict adherence to ISO 13485 Quality Management System
Implement and monitor SOPs, work instructions, and batch records
Participate in internal audits, external audits, and regulatory inspections
Handle deviations, non-conformances (NCRs), CAPA, and change controls
Process Control & Validation
Oversee process validation, equipment qualification (IQ/OQ/PQ)
Ensure traceability, l
ot control, and documentation accuracy
Work closely with QA/QC to ensure first-time-right production
Team Leadership
Lead, mentor, and supervise production operators and supervisors
Ensure regular training on GMP, safety, quality, and compliance
Foster a culture of discipline, accountability, and continuous improvement Supply Chain & Cross-Functional Coordination
Coordinate with procurement, planning, quality, engineering, and logistics
Ensure availability of raw materials and consumables to avoid downtime
Support new product introductions and scale-up activities
Safety & Compliance
Ensure compliance with EHS, workplace safety, and statutory requirements
Maintain cleanroom discipline where applicable
Key Skills & Competencies
Strong knowledge of ISO 13485, GMP, and medical device regulations
Hands-on experience in medical device manufacturing operations
Understanding of process validation, documentation, and audits
People management & problem-solving skills
Data-driven mindset with exposure to KPIs, OEE, productivity metrics
Preferred Industry: Medical Devices / Healthcare Manufacturing
Qualification: BE / BTech (Mechanical, Industrial, or related)
Preferred Experience
4–5 years in production / operations role within a medical device company
Exposure to regulatory audits (ISO, CDSCO, FDA – if applicable)
Experience working in a regulated manufacturing environment
Why Join Us
· We are an Equal Opportunity Employer and believe in diversity of workforce
· We believe in transparency, accuracy and freedom
We provide Opportunity to work in a high impact, regulated Medical Device industry
We focus on quality, compliance, and innovation
This is a Growth-oriented role with leadership exposure
Compensation: based on your current cost to the company and on the current market
Benefits: Career Development, Paid Time Off, Rewards and Recognition
Interested? want to explore more?
Want to know how to apply? can directly forward cvs to hradmin@majikmed.com
or can reach Ms. Sandhya: 7673948679