Supplier Quality Manager Medical Devices (m/f)

Description

• Operate as the Primary Quality Point of Contact to Suppliers for development and commercial products, and establish sound relationship with suppliers
• Execute established SQM processes for supplier selection, approval and ongoing management to quality oversight level
• Manage vendor-initiated changes and supplier related company-initiated changes through interactions with suppliers, internal customers, and subject matter experts
• Inform management and stakeholders of quality discrepancies and changes, provide timely impact assessments of potentially affected products, materials or processes
• Lead and/or participate in due diligence quality assessment and supplier audit program (responsibilities include preparing audits, performing audits, writing audit reports, reporting audit finding from supplier for close out of audit per established timelines)
• Define medical device supplier annual audit plan and assess, monitor and improve overall supplier performance

• BA or BS degree (preferably in chemical or mechanical engineering), with profound experience in the pharmaceutical or medical device industry
• Hands-on expertise in device manufacturing and knowledge of aseptic manufacturing preferred
• Demonstrated capability of applying risk management concepts and tools, and design control
• Understanding of the biotechnology industry and specifically combination products and experience working in a global environment preferred
• Sound knowledge of international applicable quality systems regulations and EU medical device directive, ISO 13485:2003 and ISO 14971, 21CFR part 4 and 820
• Ability to communicate clearly and professionally both in writing and verbally in English, this same ability in German is desired