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Company Description KOB MEDICAL TEXTILES PRIVATE LIMITED is a specialized textiles manufacturer based in Coimbatore, Tamil Nadu, India, with operations in Palladam. The company focuses on producing medical and technical textile products that meet stringent quality and regulatory standards for healthcare and related industries. Located on Trichy Road in Semmipalayam Village, the facility combines modern manufacturing capabilities with a focus on reliability and safety. Team members work in an environment that emphasizes process discipline, product consistency, and long-term customer partnerships.
Role Description The Senior Manager – QA & RA is a full-time, on-site role based in Palladam, responsible for leading Quality Assurance and Regulatory Affairs for medical textile products. This role oversees the design, implementation, and continuous improvement of quality systems, including process controls, documentation, inspections, audits, and corrective actions. The Senior Manager ensures compliance with applicable national and international standards, manages regulatory submissions and product certifications, and coordinates with internal teams to maintain compliant manufacturing and release practices. Daily activities include supervising QA/RA staff, reviewing batch records and test reports, handling nonconformities and customer complaints, and collaborating with production, and management to align quality and regulatory requirements with business goals. The role also involves training teams on quality and regulatory procedures and preparing for external audits by customers and certification bodies.
Qualifications
- Strong expertise in Quality Assurance for manufacturing or medical textiles, including quality systems, process validation, documentation, and root cause analysis.
- Knowledge of Regulatory Affairs for medical or technical products, such as understanding relevant standards, certifications, and compliance requirements.
- Experience leading audits and inspections, managing CAPA (Corrective and Preventive Actions), and improving quality processes across departments.
- Demonstrated ability to manage and mentor teams, coordinate cross-functional initiatives, and communicate clearly with stakeholders at all levels.
- Familiarity with textile or medical device manufacturing environments, including production workflows, testing methods, and product safety considerations.
- Strong analytical and problem-solving skills, attention to detail, and ability to make decisions based on data and regulatory expectations.
- Bachelor’s degree or higher in Textile Technology, Engineering, Quality Management, Life Sciences, or a related field; relevant professional certifications are an advantage.
- Comfort working on-site in Palladam, with readiness to engage closely with production operations and participate in shop-floor quality activities.
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