Senior Specialist Supplier Quality

India·Bangaloresenior

OtherQuality

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Key Responsibilities

Supplier onboarding

Technical Tools

OtherQuality

~1 min read

→Qualification and approval of new suppliers in accordance with internal FME processes and quality standards
→Conducting risk analyses and initial assessments of suppliers
→Assessing and ensuring compliance with supplier quality standards

Planning, organizing and conducting supplier audits (e.g. system and process audits)

Maintaining and updating supplier and quality data in the Trackwise and SAP (S/4, ECC 6.0) systems

Drafting, coordinating, negotiating and monitoring the validity of quality agreements with suppliers

The physical demands and work environment characteristics described here represent those employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

B.S., M.S. or equivalent combination of certifications in life sciences and/or engineering or physical sciences.
A degree in engineering, quality management or a comparable field
preferred.

More than 7 Years of related experience in supplier quality management, preferably in relation to supplier activities within the medical sector.
Analytical skills and a structured, solution-oriented approach to work
Strong communication skills and the ability to assert oneself
A high degree of personal responsibility and organisational skills
Ability to work in a team and intercultural competence
Knowledge of GMP requirements,
ISO 9001 and 13485 standards, QMSR/21CFR820 preferable
Regional regulations, applicable to Medical Products (Device & Drug preferred)
Understanding of Medical Products/Manufacturing processes.
In-depth knowledge of audit methods (ISO 19001)
Preferable knowledge in Dialysis machines and components or disposables. Deep technical knowledge for manufacturing processes e.g. injection molding, electronics, chemicals etc.
English & German Languages preferred.
Confident use in SAP (particularly in quality management and master data maintenance)
Experience with Trackwise or similar electronic systems
Good knowledge of Microsoft applications in general and Microsoft Excel in particular (e.g. reporting, KPI tracking)
Basic knowledge of data analysis and reporting tools would be an advantage