Hybrid Quality Manager – QMS

at ZEISS Group

• Job title: Quality Manager – QMS
• Job type: Full Time
• Experience level: Senior, Lead
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Tech skills: Cyber Security
• Location requirements: Hybrid, Bangalore, India

About the role

• Quality Manager overseeing QMS compliance and regulatory adherence at ZEISS India. Collaborating with product teams to ensure ISO standards and quality practices are met.

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.

Requirements

• Bachelor’s / Master’s degree in Sciences, Engineering, or related discipline
• 10-15 years of experience in product development teams with at least 6-7 years in Quality Management of ISO 13485 based healthcare products.
• 6-7 years of experience working with SW development teams for both medical devices installed SW as well as SaMD.
• Strong knowledge of regulations that are enforced on medical device manufacturers like EU MDR, US FDA, ANVISA, etc.
• Experience working with teams on Risk Management for Medical Devices based on ISO 14971.
• Internal Auditor / Lead Auditor certified for ISO 13485:2016.
• Knowledge of Information Security / Data Privacy Concepts
• Knowledge of and experience working with quality tools and statistical methods.
• Experience conducting Internal Audits and facing external audits on ISO 13485 and preferably MDSAP.
• Experience in working with distributed team members.
• Knowledge of several SW Development Lifecycle Models including Agile development methods.

Benefits

• Flexible work arrangements
• Professional development opportunities