Supplier Quality Lead

About the role

Wellspect, a global medical device manufacturer headquartered in Mölndal, Sweden and part of Dentsply Sirona, is looking for a Supplier Quality Lead. The role covers supplier quality management, CAPA coordination, audit support and supplier performance monitoring, acting as the process owner for assigned procurement processes.

Key responsibilities

• Track supplier-related raw material and component non-conformities through to closure, coordinating internal teams and suppliers
• Coordinate supplier CAPA processes end-to-end, including root cause analysis, action plans and effectiveness verification
• Support supplier quality and procurement audits, track quality performance and continuous improvement plans
• Clarify responsibilities and deadlines across Purchasing, Quality, R&D, Engineering, Regulatory, Planning and Production
• Hold quality alignment meetings with suppliers, support process validation, and support supplier selection, sourcing research and qualification in product development projects
• Manage PPAP activities and coordinate supplier change notification evaluations and due diligence and sustainability assessments
• Develop supplier quality and purchasing procedures, templates and work instructions, and act as the designated process owner for assigned procurement processes
• Perform data analysis for assigned KPIs and report supplier performance

Required profile

• Minimum 5 years of professional experience in supplier quality management, quality assurance or purchasing/procurement
• Bachelor's degree in Engineering, Sciences or a related discipline
• Experience in the medical device industry or similarly regulated sectors, and with international suppliers, is preferred
• Eligible to work in the country where the position is based

Required skills

• Strong proficiency in procurement, purchasing and sourcing management
• In-depth knowledge of ISO 13485 and ISO 9001; familiarity with MDR and FDA requirements preferred
• Familiarity with 8D, 5 Whys, Lean, Six Sigma and PPAP
• Ability to track actions and deadlines in ERP and/or QMS systems
• Excellent written and spoken English, and strong analytical and communication skills