Senior Supplier Quality Engineer EMEA (d/f/m)

As our Senior Supplier Quality Engineer EMEA (d/f/m) you are responsible for end to end supplier management, which includes oversight of supplier sourcing and selection process, as well as supplier qualification (audit), monitoring, development and decommissioning. Furthermore, in this role you will be the instance being involved in any outsourcing activity and assures that product or service related specifications or requirements are defined and communicated and that mandatory contracts are being created.

Key Duties & Responsibilities

• Focused on supplier quality, responsible for ongoing compliance of the Quality Management System according to the respective regulations
• Responsible for compliant qualification, evaluation, development and performance monitoring of suppliers. 
• Assist to define the mandatory incoming goods acceptance criteria based on product risk and category
• Establish supplier performance KPIs and a thus-related dashboard 
• Collaborate with product management to synchronize supplier-related activities with product lifecycle (IOL, Purchased FGs) from product qualification until phase-out 
• Plan and conduct the supplier audit program. Support distributor and internal audit.
• Assist in CAPA and nonconformity management activities
• Responsible for creation of supplier quality agreements based on product/service category
• Plan and conduct internal quality related trainings
• Collaborate with product management to synchronize supplier-related activities with product lifecycle (IOL, Purchased FGs) from product qualification until phase-out 
• Lead and participate monthly Global Supplier Quality Performance Review Meeting

Skills and Competencies

• Bachelor’s degree in a technical discipline required or comparable background (engineering, industrial engineering, etc.)
• At least 5 years of experience in management of quality systems
• Profound knowledge of ISO 9001 and/or ISO 13485 and Good Distribution Practice is mandatory
• Experience in managing Clinical CROs or knowledge of Good Clinical Practices is highly preferred
• 3 years of supplier control experience is a benefit. Auditor certificate is a plus

Languages

• Fluent English and German (written and spoken)