Senior Specialist Supplier Quality

Fresenius Medical Care; Bengaluru; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Fresenius Medical Care is looking for a Supplier Quality Management professional in Bengaluru, Karnataka. The role involves overseeing supplier quality management activities for the EMEA and US regions.

Key responsibilities include supplier onboarding, conducting audits, and maintaining supplier quality data. Candidates should have over 7 years of experience, preferably from the medical sector, along with strong analytical skills and familiarity with ISO standards and SAP.

Qualifications

• Over 7 years of experience in supplier quality management.
• Strong analytical skills and solution-oriented approach.
• In-depth understanding of medical products and manufacturing processes.

Responsibilities

• Manage supplier onboarding and quality standards.
• Conduct and document supplier audits.
• Maintain quality data in SAP and Trackwise.

Skills

Analytical skills

Communication skills

Teamwork

Intercultural competence

Knowledge of GMP requirements

ISO 9001 and 13485 standards

Knowledge of dialysis machines

Education

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

Degree in quality management or related field

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 with internal 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 use in 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