Senior Global Supplier Quality Professional II

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeGlobal Supplier Quality Systems Professional II is responsible for leading and executing global supplier and material governance programs that support material qualification and material lifecycle management across the supply chain. This role ensures that new suppliers materials and components are effectively assessed qualified approved and integrated in compliance with quality regulatory and business position serves as a key liaison between suppliers and cross-functional stakeholders including Quality Supply Chain Procurement R&D Regulatory Affairs Operations and Manufacturing to facilitate supplier selection material onboarding risk assessment qualification activities and ongoing supplier performance management. The role drives robust qualification standards material approval workflows and governance frameworks that support product quality regulatory compliance patient safety and uninterrupted the Global Supplier Quality Systems Professional supports supplier change management and quality agreement programs to ensure supplier-initiated changes sourcing transitions material updates process modifications and quality system changes are appropriately evaluated communicated and implemented. The position supports strategic supply chain initiatives through effective supplier partnerships risk mitigation performance monitoring and continuous improvement activities that strengthen supplier reliability and operational excellence across the global within a regulated environment the role ensures supplier change management and quality agreement activities align with applicable global standards and regulations (e.g. ISO 13485 FDA 21 CFR Part 820 and other applicable regional requirements). Responsibilities include oversight of supplier change notifications throughout the supplier lifecycle; ensuring supplier adherence to contractual quality and notification obligations; facilitating timely supplier communications and documentation updates; and implementing appropriate controls to mitigate quality regulatory business continuity and supply role monitors supplier compliance with change notification requirements and Supplier Quality Agreements through performance ResponsibilitiesMaterial Supply Chain Vendor Change Management Quality Agreement Governance & ComplianceLead global quality material onboarding and lifecycle management activities ensuring materials are appropriately qualified risk assessed and aligned with supplier qualification requirements to support a compliant and resilient supply the global Vendor Change Notification (VCN) Supplier Change Management and Supplier Quality Agreement (SQA) supplier-initiated changes (e.g. material component process equipment facility subcontractor test method and quality system changes) are identified reviewed approved and implemented in accordance with Quality Management System (QMS) requirements Supplier Quality Agreements and regulatory negotiate implement maintain and periodically review Supplier Quality Agreements to ensure clear definition of quality responsibilities and change notification and continuously improve supplier change management and Supplier Quality Agreement procedures policies templates and governance processes to ensure consistency compliance and effectiveness across the supplier supplier compliance with contractual quality obligations and change notification requirements ensuring timely communication and adherence to agreed quality key performance indicators (KPIs) related to supplier change management and quality agreement trends in supplier changes audit observations quality events and contractual compliance metrics to identify emerging risks and improvement continuous improvement initiatives that enhance supplier quality governance and regulatory Compliance & Inspection ReadinessEnsure supplier change management and Supplier Quality Agreement activities comply with applicable regulatory and quality requirements including ISO 13485 FDA 21 CFR Part 820/QMSR GMP and other relevant internal audits external audits customer audits and regulatory inspections related quality agreements and change management inspection-ready documentation records risk assessments quality agreements and audit evidence supporting supplier oversight evolving regulatory requirements and implement updates to supplier governance processes and quality agreements as -Functional CollaborationServe as the primary Supplier Quality representative for supplier change management and Supplier Quality Agreement activities across global with R&D Engineering Regulatory Affairs Operations Manufacturing Procurement and Legal to evaluate supplier risks change impacts and contractual quality cross-functional decision-making and risk assessments to support timely implementation of supplier changes and quality agreement strong partnerships with suppliers to ensure proactive communication effective governance and management of quality and compliance QualificationsBachelors degree in life sciences engineering or related field required.8 years of progressive quality experience in Supplier Quality Materials Quality or Quality Systems in a regulated in medical device pharmaceutical or other highly regulated experience working with global suppliers and cross-regional knowledge of Quality Management Systems (QMS) materials and supplier with regulatory standards such as ISO 13485 ISO 9001 FDA 21 CFR Part 820 and/or GMP in quality tools and methodologies (e.g. FMEA SPC process validation statistical analysis).Experience managing vendor change notifications supplier audits CAPA systems and change control problem-solving and root cause analysis project management skills with ability to manage multiple initiatives communication and stakeholder management skills across technical and non-technical to influence without authority and drive accountability across a global supply level of analytical capability with experience interpreting supplier performance QualificationsSix Sigma Green/Black BeltWhat We OfferCompetitive base salary performance bonusComprehensive benefits package (health dental vision 401k etc.)Structured mentorship and professional development programsExposure to cutting-edge pharmaceutical manufacturing technologiesClear career progression path toward Senior Manufacturing Engineer rolesCollaborative and supportive work culture#LI-Remote