Supplier Quality Lead

Key Responsibilities

• Track supplier-related raw material and material non-conformities through to closure, ensuring cross-functional coordination between internal teams and suppliers.

• Coordinate supplier CAPA processes end-to-end; monitor the completion of root cause analysis, action plans, implementation, and effectiveness verification.

• Support supplier quality and procurement audits; track supplier quality performance and continuous improvement plans.

• Clarify responsibilities, action items, and target deadlines across Purchasing, Quality, R&D, Engineering, Regulatory, Planning, and Production teams.

• Conduct quality alignment meetings, technical correspondence, and action tracking with suppliers; support process validation activities when required.

• Support supplier selection, sourcing research, and qualification activities within Product Development Projects (PDP) and operational projects.

• Manage Production Part Approval Process (PPAP) activities and ensure all related documentation is fully completed.

• Coordinate the evaluation of supplier change notifications (SCN) and support the necessary qualification/verification activities.

• Coordinate supplier due diligence and sustainability assessments; develop supplier quality and purchasing procedures, templates, and work instructions.

• Act as the designated Process Owner for assigned procurement processes.

• Execute the responsibilities of Correction Handling Officer, Investigator, Measure Officer, and CAPA Owner in accordance with applicable procedures.

• Perform data analysis for assigned KPIs, report supplier performance, and drive continuous improvement in line with the Wellspect Culture Vision

Key Performance Indicators (KPIs)

• On-time closure rate and effectiveness verification rate of supplier non-conformities and CAPA actions.

• Supplier quality performance indicators (non-conformity rate, PPM, and recurring non-conformities).

• On-time completion of PPAP and supplier qualification activities.

• Supplier action compliance with deadlines and progress of supplier development plans.

Requirements 

• Strong proficiency in procurement, purchasing, and sourcing management.

• Proven experience in supplier quality management, raw material/component non-conformities, and CAPA processes.

• In-depth knowledge of ISO 13485 and ISO 9001 standards; familiarity with MDR and FDA requirements is preferred.

• Familiarity with problem-solving and analytical methodologies such as 8D, 5 Whys, Lean, Six Sigma, and PPAP.

• Hands-on ability to track actions, documentation, and deadlines via ERP and/or Quality Management Systems (QMS).

• Professional written and verbal English proficiency to work independently with international suppliers.

• Excellent communication, planning, reporting, problem-solving, and cross-departmental coordination skills.

• Solid understanding of core operational processes and standard operating procedures.

• Strong analytical capability to review, summarize, and extract actionable insights from data and reports.

• Analytical thinking, high attention to detail, and data-driven decision-making.

• Root cause analysis expertise, solution development, and tracking action effectiveness.

• Workload prioritization, organizational agility, planning, and time management.

• Proactive, result-oriented mindset with a strong sense of process ownership.

• Collaborative teamwork, stakeholder management, and persuasive communication skills.

• Minimum 5 years of professional experience in supplier quality management, quality assurance, or purchasing/procurement processes.

• Experience in the medical device industry or similarly regulated sectors, along with exposure to working with international suppliers, is preferred.

• Bachelor’s degree in Engineering, Sciences, or a related discipline from an accredited university.