Head of Supplier Quality Management

The Head of Supplier Quality Management ensures that all suppliers meet stringent industry standards, overseeing audits, quality agreements, and compliance with regulatory requirements e.g. ISO 9001/13485 and GMP/GDP. This role maintains compliance with international and local regulations, aligning supplier activities with industry standards and legal requirements, while identifying and mitigating risks to prevent supply chain disruptions. Supplier Quality Management - Develops, implements, and oversees global supplier quality strategies aligned with regulatory and company requirements. - Defines, enforces, and improves supplier quality standards. - Conducts supplier audits, assessments, and evaluations; develops risk‑based audit schedules. - Develops and reviews audit agendas, reports, findings, and responses; conducts audits of vendors as needed. - Establishes supplier KPIs and drives supplier corrective actions and quality improvements. - Establishes supplier classification and control methodologies based on risk. - Capable of developing statistically sound sampling plans and performing advanced data analysis. - Collaborates with Procurement on supplier metrics and actions; works closely with Field Service to understand customer issues and identify improvements. - Supplier Development & Continuous Improvement - Drives continuous improvement programs using Lean, Six Sigma, DMAIC, 8D, and other structured problem‑solving methods. - Leads CAPA activities end‑to‑end and ensures effectiveness verification. - Provides technical guidance to suppliers on FMEA, Control Plans, V&V, Risk Engineering, SPC, and advanced statistical tools. - Identifies and incorporates internal and external best practices into business processes. - Supports Quality & Sustaining Engineering in project execution and design transfer activities. - Maintains global accountability for design/supplier quality performance, sterilization/labeling compliance, and design transfer success. Risk Management & Compliance - Identifies, evaluates, and mitigates supplier quality risks across the global supply base. - Ensures compliance with global industry regulations and standards (ISO, MDSAP, MDR, etc.). - Jointly accountable with QS and RA Leadership to maintain an effective global Quality System. - Leads inspection readiness efforts and assists with hosting on‑site inspections. - Keeps abreast of emerging global regulations, trends, and requirements. - Supports integration of acquisitions into the global QMS. - Collaborates cross‑functionally to develop AI/ML‑enabled processes for accelerated quality analytics and trend detection. Leadership accountability - Leads through company values and reinforces a strong global Quality Culture. - Effectively establishes and communicates a Zero Defects vision; aligns teams around required strategies, objectives, and plans. - Builds a culture of action, accountability, and on‑time delivery. - Sets SMART goals, provides continuous feedback, and mentors team members for development and career progression. - Anticipates obstacles and creates risk‑based contingency plans to achieve AOP and long‑term goals. - Demonstrates responsible risk‑taking and understands end‑to‑end business impacts. - Shows visible commitment to efficiency programs and continuous improvement initiatives. - Preserves personal relationships even in difficult or dynamic situations. - Leads with a hands‑on approach to drive details as needed to meet/exceed deliverable expectations. Cross-Functional Collaboration - Partners closely with Procurement, Engineering, Operations, Manufacturing, RA, and QS. - Participates in supplier selection, qualification, onboarding, and performance reviews. - Supports Quality Agreements, Deviations, Change Control, CAPA, Management Review, and Quality Metrics processes. - Actively contributes to Management Review preparation and leadership. - Builds internal synergies, supports operating goals, and collaborates across functions globally. Requirement: Education / Professional Certification - Bachelor´s or Master´s degree in engineering, medical technology, natural sciences, physics/optics, technology, or a related technical field ; MBA is a plus (Engineering, Quality, Regulatory, Operations Management, or related). - Demonstrated experience with ISO 9001/ 13485/ MDSAP and industry/regulatory frameworks (e.g. FDA 21 CFR 820 including 820.30, EU MDR 2017/745) - Knowledge of ISO 14971, IEC 62304, ICH Q10, EU GMP, and NMPA regulations Professional Certifications - Six Sigma (Green Belt / Black Belt) preferred. - Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent (optional but advantageous). - APQP / PPAP / Supplier Quality certifications Mandatory. Industry & Functional Experience - 13–15+ years in Quality, Supplier Quality, Manufacturing Quality, or Regulatory within Medical Devices or Pharmaceuticals. - Minimum 8–10 years in leadership roles managing global or multinational teams. - Experience managing external suppliers, contract manufacturers, outsourced manufacturing and global supply chains. - Demonstrated success leading supplier audits, GxP vendor management, and compliance programs. - Technical & Regulatory Experience - Strategic & Organizational Experience - Leadership & Behavioral Skills - Digital & Analytical Skills - Communication & Collaboration Skills Technical Skills - Expert use of Supplier Quality tools: - FMEA (DFMEA/PFMEA) - Control Plans - APQP / PPAP - Risk management (ISO 14971) - CAPA methodology - Statistical analysis (SPC, DOE) - Ability to establish supplier process controls aligned with Zero Defects. - Proficient in data analytics and quality dashboards. - Competent with MS Office, QMS software, ERP systems; SAP and Trackwise, Veeva is a plus. Working conditions & Other Attributes. - Global role across time zones; international travel required to sites, suppliers, and authorities/Notified Bodies. - Mix of office, development lab, and manufacturing floor environments; availability during audits/inspections and key project milestones. - Indicative team workload distribution guidelines: approximately 60% project support, 30% Quality Standards & Specifications (QSS), 10% Continuous Improvement (CI) — to be tailored by region/business needs. - Adherence to company policies, confidentiality, and compliance requirements.