Senior Specialist Supplier Quality

CH01 CHE Fresenius Medical Care (Schweiz) AG; Bengaluru; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

CH01 CHE Fresenius Medical Care (Schweiz) AG in Bengaluru seeks an experienced Supplier Quality Manager to lead regional supplier quality activities for EMEA and US. You will manage onboarding, risk assessments, audits and QA agreements to ensure compliance with GMP and ISO standards.

Key responsibilities include developing audit programs, maintaining master data in Trackwise and SAP, and driving corrective actions across a global supplier network with cross-functional and intercultural

Qualifications

• 7+ years of supplier quality management experience, preferably in medical sector.
• Analytical, structured, solution-oriented approach.
• Strong communication skills and ability to assert oneself.
• Intercultural teamwork and responsibility.

Responsibilities

• Onboard and approve suppliers per internal FME processes and quality standards.
• Conduct risk analyses and initial supplier assessments.
• Assess compliance with supplier quality standards.
• Plan and conduct supplier audits (system/process).
• Develop and maintain the supplier audit program.
• Document audit findings and evaluate supplier performance.
• Follow up on audit non-conformities and actions.
• Ensure timely and sustainable corrective actions.
• Verify effectiveness of implemented measures.
• Maintain supplier and quality master data in Trackwise and SAP.
• Support analysis of quality KPIs.
• Draft, coordinate and monitor Quality Agreements with suppliers.

Skills

Supplier quality management

Audit management

GMP knowledge

ISO 9001/13485 knowledge

Data analysis

English & German

Education

Life sciences or engineering degree

Tools

SAP QM

Trackwise

Microsoft Excel

Job description

PURPOSE AND SCOPE

Management of the Supplier Quality Management activities & resources for the region EMEA and US. Management der Aktivitäten und Ressourcen des Qualitätsmanagements für Lieferanten in der Region EMEA und US.

PRINCIPAL DUTIES AND RESPONSIBILITIES

• Supplier onboarding 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
• Audit Management Planning, organizing and conducting supplier audits (e.g. system and process audits)
• Developing and maintaining the supplier audit program
• Documenting audit findings and evaluating supplier performance
• Following up on audit non-conformities and action plans
• Ensuring the timely and sustainable implementation of corrective actions
• Verifying the effectiveness of implemented measures
• Master Data Management Maintaining and updating supplier and quality data in the Trackwise and SAP (S/4, ECC 6.0) systems
• Ensuring data quality and consistency Supporting the analysis of quality-related key performance indicators
• Quality Agreements (QAAs) Drafting, coordinating, negotiating and monitoring the validity of quality agreements with suppliers
• Ensuring the contractual implementation of quality requirements
• Providing support in the event of escalations and supplier development measures

PHYSICAL DEMANDS AND WORKING CONDITIONS

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.

EDUCATION

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.

EXPERIENCE AND REQUIRED SKILLS

• 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
• Creating a future worth living. For patients. Worldwide. Every day. Fresenius Medical Care is the world's leading provider of products and services for individuals with kidney disease of which approximately 4.5 million patients worldwide regularly undergo dialysis treatment. United by a shared purpose of creating a future worth living for chronically and critically ill people, we care for around 292,000 dialysis patients around the globe. In addition, we operate around 35 global production sites to provide products such as dialysis machines, dialyzers, and related disposables. We aim to continuously improve our patients’ quality of life by offering them high-quality products as well as innovative technologies and treatment concepts.