Quality management system

Company Description Galaxy Innovations is a trusted manufacturer and supplier of orthopaedic surgical instruments and sterile, autoclave-compatible aluminum instrument containers, boxes, and trays that meet the demands of modern healthcare. The company focuses on precision-engineered products that enhance surgical performance, support safe sterilization, and optimize instrument management. Its laser-engraved aluminum containers and customized storage solutions emphasize durability, reliability, and adherence to hospital sterilization protocols. Driven by innovation, quality, and customer satisfaction, Galaxy Innovations serves hospitals, healthcare institutions, distributors, and medical professionals with advanced engineering and superior craftsmanship.
Role Description The Quality Management System (QMS) professional will oversee, maintain, and improve the organization’s quality processes and documentation to ensure compliance with relevant medical device and healthcare standards. This full-time, on-site role is based in Delhi, India, and includes developing and updating SOPs, work instructions, and quality manuals, as well as monitoring adherence across production, sterilization, and packaging operations. Day-to-day responsibilities include conducting internal audits, managing non-conformities and corrective/preventive actions (CAPA), supporting risk assessments, and coordinating with cross-functional teams to resolve quality issues. The role also involves training team members on quality and regulatory requirements, preparing for external audits and inspections, and analyzing quality data to drive continuous improvement initiatives in manufacturing and instrument management processes.
Qualifications
Strong knowledge of Quality Management Systems, including ISO 13485 or similar medical device standards, and practical experience in implementing and maintaining QMS in a manufacturing environment.
Skills in internal auditing, CAPA management, root cause analysis, and risk assessment methods (e.g., FMEA, risk matrices) to support continuous improvement and compliance.
Experience with documentation control, SOP and work instruction development, and process mapping to ensure clear, consistent, and audit-ready quality records.
Familiarity with sterilization processes, autoclave operations, and hospital sterilization protocols, especially related to medical instruments and aluminum containers.
Proficiency in data analysis, report writing, and use of quality tools (e.g., control charts, Pareto analysis) to monitor performance and identify improvement opportunities.
Effective communication and collaboration skills to work with production, engineering, regulatory, and customer service teams and to deliver training on quality standards.
Bachelor’s degree in Engineering, Quality Management, Biomedical, or a related technical field; professional certifications in quality or auditing (e.g., ISO Internal Auditor) are an advantage.
Prior experience in medical device, healthcare, or surgical instrument manufacturing is preferred, along with a strong attention to detail and a commitment to safety and regulatory compliance.

Work arrangement
No