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In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.
Establish and successfully executesupplier management planswhich will align to overall business objectives
Maintain a strong collaborativepartnership
supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)
ExecuteSupplier Corrective Action Requests(SCAR) with suppliers, ensuring effective and timely closure
Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance includingsupplier changerequest.
Evaluate potential new or future suppliers and support supplierselection processwith the cross-functional team
Participate in cross-functional teams of design engineering and quality engineering to work with suppliers duringproduct developmentand ensures agreement for manufacturable, cost-effective designs
Approves components for use in products by drivingProduct Approvalactivities with the suppliers
Supports Supplier evaluation,auditmanagement and related records
Supports the evaluation and development ofQuality Agreements and purchasing specificationswith suppliers
Support the development of anIncoming Inspection strategyon purchased products
Bachelor’s degree in engineering or related science
Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry
Experience working with suppliers and supplier engagement activities
Knowledge of sterilization process is preferred
Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations
Familiarity with MasterControl, SAP and working knowledge of statistical data analysis
Fluent in English
Thorough understanding of validation activities and risk management principles and techniques
Strong problem-solving and critical thinking skills
Negotiation skills and collaborating with suppliers
Ability to work under high volume production and fast changing environment
Willingness to work in a cross-functional team with different time zones
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