Senior Specialist Supplier Quality

Freseniusmedicalcare; Bengaluru; On-site; INR 1,400,000 - 2,200,000; Full time

Job summary

Freseniusmedicalcare seeks a skilled Supplier Quality Manager to lead regional supplier quality management activities in Bengaluru. You will oversee onboarding, risk assessments, and ensure adherence to GMP and QMS standards across suppliers in the EMEA region and the US.

Responsibilities include planning and conducting supplier audits, maintaining data in Trackwise and SAP, drafting Quality Agreements, and driving corrective actions.

Qualifications

• Over 7 years of supplier quality management experience in the medical sector.
• Analytical, structured, and solution-oriented approach to work.
• Strong communication and organizational skills with intercultural awareness.
• Knowledge of GMP requirements and ISO 9001/13485 standards.
• Experience with SAP QM, Trackwise, and master data management.

Responsibilities

• Qualify and approve new suppliers per internal FME processes and quality standards.
• Conduct risk analyses and initial supplier assessments.
• Ensure compliance with supplier quality standards.
• Plan, organize, and conduct supplier audits; develop audits programs.
• Document audit findings and evaluate supplier performance; follow up on non-conformities.
• Maintain supplier data in Trackwise and SAP; ensure data quality.
• Draft and monitor Quality Agreements with suppliers; support supplier development.
• Drive corrective actions and verify effectiveness of implemented measures.

Skills

Analytical skills

Structured, solution-oriented

Strong communication skills

Organizational skills

Intercultural competence

GMP knowledge

ISO 9001/13485 knowledge

Understanding of medical products/manu

English & German languages preferred

Education

B.S., M.S. in life sciences/engineering/physical sciences

Engineering/quality management degree or equivalent

Tools

SAP

Trackwise

Microsoft Excel

Job description

PURPOSE AND SCOPE:

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

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Supplier onboarding

• Qualification and approval of new suppliersin accordance withinternal FME processes and quality standards
• Conducting risk analyses and initial assessments of suppliers
• Assessing and ensuring compliance with supplier quality standards

AuditManagement

• Planning,organizingand conducting supplier audits (e.g.system and process audits)
• Developing andmaintainingthe supplier auditprogram
• Documenting audit findings and evaluating supplier performance
• Following up on audit non-conformities and action plans
• Ensuring thetimelyand sustainable implementation of corrective actions
• Verifying the effectiveness of implemented measures

Master Data Management

• Maintaining and updating supplier and quality data in theTrackwiseand SAP(S/4, ECC 6.0)systems
• Ensuringdataqualityandconsistency
• Supporting the analysis of quality-related key performance indicators

Quality Agreements (QAAs)

• Drafting, coordinating,negotiatingandmonitoringthe validity of quality agreements with suppliers
• Ensuring the contractual implementation of quality requirements
• Providing supportin the event ofescalations 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,qualitymanagementor 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 communicationskills and the ability to assert oneself
• A high degree of personal responsibility andorganisationalskills
• Ability to work in a team and intercultural competence
• Knowledge of GMP requirements,
• ISO9001 and 13485standards,QMSR/21CFR820 preferable
• Regional regulations, applicable to Medical Products (Device & Drug preferred)
• Understanding ofMedical Products/Manufacturing processes.
• In-depth knowledge of audit methods (ISO19001)
• Preferable knowledge in Dialysis machines and components or disposables. Deep technical knowledgeformanufacturingprocessese.g.injection molding, electronics,chemicalsetc.
• English &GermanLanguages preferred.
• Confident usein SAP (particularly in quality management and master data maintenance)
• Experience withTrackwiseor similarelectronic 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