Quality Manager

Job Title:

About The Role

Key Responsibilities

• Develop, implement, and continually improve Operational Quality Systems.
• Analyze Quality Systems data to identify trends and recommend improvements for achieving organizational and strategic quality objectives.
• Serve as Management Representative for Quality Management Systems.
• Own processes for internal/external audits and supplier controls.
• Lead and manage the Quality teams through QA and QC activities.
• Own departmental performance objectives.
• Plan, promote, and organize Quality Systems training activities for site teams.
• Plan and develop site-level Management Review processes.
• Ensure product quality and compliance through robust site-level Quality Systems management.
• Promote and observe company policies on safety, quality, and productivity.
• Other duties as assigned.
  

Skills & Qualifications

• Bachelor’s degree from a recognized university; advanced degrees preferred.
• Minimum 5-10 years of hands-on experience in quality management within a regulated manufacturing environment, preferably in medical device tubing, extrusion, and/or polymer processing.
• In-depth knowledge of Indian medical device regulations (CDSCO - Central Drugs Standard Control Organization), ISO 13485, and global standards such as FDA 21 CFR Part 820.
• Experience with implementation and maintenance of ISO 13485 certification and regulatory audits (CDSCO, US FDA, EU MDR).
• Strong understanding of risk management, validation protocols, and documentation required for medical device manufacturing.
• Proficiency in managing and leading cross-functional teams, including Quality Engineers, QC Supervisors, and Documentation teams.
• Demonstrated track record in supplier quality management and handling customer/supplier audits and surveys.
• Experience with statistical tools (Minitab or equivalent), EQMS (Electronic Quality Management Systems), and Measurement System Analysis (MSA).
• Working knowledge of Lean Manufacturing and Six Sigma methodologies; relevant certifications are a plus.
• Familiarity with compliance requirements including REACH, RoHS, WEEE and PFAS.
• Excellent communication skills in English; knowledge of Tamil/Hindi is an advantage.
• Proficient in Microsoft Office Suite (Excel, Word, Outlook); experience with ERP systems is preferred.
• Ability to travel within India as necessary.