Job Description - QualityProfessional
Position Headline
Responsible and performs a
range of specified quality management system process, document control system,
training management system, Supplier management system, Handling environmental
regulatory topics like E-Waste Management, Plastic Waste Management, Battery Waste
Management, Bio-medical Waste Management, etc.,
Areas of Responsibility:
1. Administering and driving Quality Management System elements compliance,
in line with international quality standards like ISO 9001 and ISO 13485 and
SHS global requirements, within the organization.
2. Partnering with all relevant stakeholders and ensure the
compliance of Customer Service processes in alignment with global CS Quality
requirements.
3. Deploy the workflow of Document Control process from end-to-end by
coordinating with all relevant stakeholders and process owners within the
organization.
4. Perform and support a range of specified Quality Management System
processes, like participating in Quality Audit process (both internal and
external), managing CAPA process, planning and driving Quality Management
Review process, etc.,
5. Engage in Supplier Quality management, change control process and
other QA responsibilities as assigned.
6. Organize within organization on monitoring all Quality related
KPIs and drive for continuous improvement.
7. Responsible to manage training management portal and deploy trainings
to employees across the organization in identified specific Quality process.
8. Supports Quality Management System elements implementation and
monitoring in Zone India.
9. Prepare and support with registration and periodic reports
submissions with authorities through relevant portals by coordinating with all stakeholders
internally and contribute for collaboration externally with Central Pollution
Control Board and Ministry of Environment.
Education and Experience
? Graduate or Postgraduate in Engineering or master's degree in science with 5 - 8 years of experience.
? Experience in Medical Device Industry with at least 3 years in Quality function.
? Hands on experience of Quality Management System in medical device industry is a requisite.
? Certified Lead Auditor in ISO 9001/ 13485 and/or ASQ Certified Quality Engineer (CQE) is preferred
