Supplier Quality Engineer

October 9

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Convatec

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Wound Therapeutics • Ostomy Care • Continence & Critical Care • Infusion Devices • Medical Devices

5001 - 10000

Description

• Support the maintenance and improvement of ConvaTec’s Global Supplier Quality program. • Focus on establishing, maintaining, and improving supplier performance metrics, policies, and procedures in administering quality relationships with suppliers globally. • Investigations relating to suppliers issues through the SCAR and CAPA process. • Internal Investigations through the NC and CAPA process. • Support and lead where appropriate, supplier selection, evaluation, and approval. • Conduct Supplier audits. • Generate and monitor appropriate key performance indicators to assess supplier performance in a timely manner to drive the resolution of corrective actions from the suppliers. • Raise appropriate questions or concerns regarding regulatory compliance to appropriate authorities regarding Purchasing Control activities. • Driving change requests through to closure for our ECCF and CCR process. • Demonstrate high commitment to quality and customer service based upon customer needs. • Build strong relationships with customers, suppliers, stakeholders, and support groups worldwide to meet the demands of a changing business environment. • Demonstrate technical knowledge and principles in relation to medical devices in line with ISO13485 ISO9001 GMP Parts 201 and 211, EU MDR Authority (if applicable): Execution and sign off final release for third party product batches to support base business and to ensure compliance to specifications and documentation requirements.

Requirements

• BS or higher degree qualified in Science or Engineering • Quality Auditor or Lead Auditor certification is preferred in ISO9001 or ISO13485 • Minimum 3 years of experience in the medical device industry • Minimum 2 years of experience in Supplier Quality Control • Experience in internal and supplier-related CAPA/ NC/ SCAR initiation. • Knowledge of ISO13845 and FDA medical requirements. • Statistical skills. • Strong prioritization and coordination skills. • Ability to work with electronic databases (i.e. Documentum, Trackwise, SAP). • Advanced computer management skills including Microsoft Word, Excel, and Visio. • Proactivity and flexibility to meet priorities and achieve deliverables. • Ability to negotiate and partner with internal and external customers to enhance operational effectiveness.