About the role
As Quality Manager, you will lead all Quality Management activities, including QA and QC of our new Chennai medical device tubing extrusion site. This role also has the potential to increase to multisite responsibilities with additional Medical Device and Polymers manufacturing sites within India. You’ll drive operational excellence by developing, implementing, and monitoring processes, people, metrics, and tools aligned with internal, regulatory, and customer standards.
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.