ZEISS in India

ZEISS in India is headquartered in Bengaluru and present in the fields of Industrial Quality Solutions, Research Microscopy Solutions, Medical Technology, Vision Care and Sports & Cine Optics.

ZEISS India has 3 production facilities, R&D center, Global IT services and about 40 Sales & Service offices in almost all Tier I and Tier II cities in India. With 2200+ employees and continued investments over 25 years in India, ZEISS’ success story in India is continuing at a rapid pace. 

Further information at ZEISS India.

This individual will work with the Head of Quality to make sure that the QMS (Quality Management System) is maintained with the required processes and templates, coordinated, and synchronized with the Global harmonized QMS, QMS requirements of the Competence Centre are satisfied and that the products of the division are complaint with the QMS and ISO 13485, MDSAP and applicable regulatory requirements. This role will report to the Head of Quality.

Duties and Responsibilities

• Support development of SOPs / Work Instructions / Working documents for product development and support processes.

• Coordinate with process owners and ensure standardization in QMS documentation.

• Track the QMS changes as per regulatory standards and ensure compliance.

• Conduct trainings to help teams understand QMS processes and standards.

• Guide Project / Product development team to follow QMS processes along with Quality Specialist(s).

• Ensure regular Management reporting as per QMS and quality standard requirements.

• Monitor project deliverables and ensure they are compliant with the defined QMS.

• Work closely with QMR to ensure compliance with QMS standards and continuous improvement initiatives, including audit NCs, customer complaints, etc., across teams and suggest any system wide CAPAs.

• Help in audit planning (internal and external) and support implementation, including intermediate cross-functional audits.

• Drive and support project/product teams in root-cause analysis of defects and defect prevention activities.

• Maintain the Quality Management database and ensure compliance with standard norms (documentation, naming convention etc.).

• Help in defining Project / Product metrics and support analysis and corrective action where necessary.

• Participate in Product / Project Cyber Security Assessment reviews.

• Train and authorize team members on the internal Document Management System.

o   Bachelor’s / Master’s degree in Sciences, Engineering, or related discipline

o   10-15 years of experience in product development teams with at least 6-7 years in Quality Management of ISO 13485 based healthcare products.

o   6-7 years of experience working with SW development teams for both medical devices installed SW as well as SaMD.

o   Strong knowledge of regulations that are enforced on medical device manufacturers like EU MDR, US FDA, ANVISA, etc.

o   Experience working with teams on Risk Management for Medical Devices based on ISO 14971.

o   Internal Auditor / Lead Auditor certified for ISO 13485:2016.

o   Knowledge of Information Security / Data Privacy Concepts

o   Knowledge of and experience working with quality tools and statistical methods.

o   Experience conducting Internal Audits and facing external audits on ISO 13485 and preferably MDSAP.

o   Experience in working with distributed team members.

o   Knowledge of several SW Development Lifecycle Models including Agile development methods.

Your ZEISS Recruiting Team:

Saptarshi Chowdhury