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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

• It is a Full Time తయారీ job for candidates with 4 - 6 years of experience.