Quality Manager
Share
Job Location:
Monthly Salary:
Posted on:
23-10-2025
Vacancies:
1 Vacancy
Job Summary
Job Title:Quality Manager Medical Device & Polymers
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. Youll 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:
- Bachelors 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.
Required Experience:
Manager
Key Skills
- APQP
- Quality Assurance
- ISO 9001
- Lean Six Sigma
- PPAP
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Control
- Quality Management
- As9100
- Manufacturing
About Company
As a leader in specialty chemicals, Lubrizol's mission is to be an essential ingredient in our customers' success. We are a market-driven, specialty chemical company with innovative technologies that include lubricant additives for engine oils and driveline fluids, industrial lubrica ... View more
