Responsable de Missions Audit clé dans l'audit légal et contractuel chez Exco Socodec. Supervisant les équipes et assurant la qualité des travaux, avec un portefeuille diversifié de clients.
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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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