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Posted: Sunday, September 3, 2017 1:58 AM

The Senior Supplier Quality Engineer will work directly with Valeant Finished Good (FG)/External Manufacturing (EM) suppliers to provide sustaining supplier quality management and routine support related EM Supplier Qualification and Monitoring requirements. In addition, the position will ensure Finished Good/External Manufacturing suppliers are compliant to all regulatory (US and International) and Valeant requirements.Identify and implement effective supplier quality management systems at the EM supplier sites to support due diligence, supplier selection, qualification, monitoring, disqualification, supplier risk management and mitigation activities in order to ensure a sustainable and compliant supplier quality management system with Valeant EM suppliers in order to meet or exceed internal and external supplier management requirements. Support North America EM supplier quality management team in identifying opportunities for improvements for both EM suppliers as well Valeant EM Supplier Quality Management System which include the following which are not all inclusive: Initiate and drive to closure Supplier Investigation Corrective Action Requests (SICAR).Initiate and negotiate Quality Agreements with new EM Suppliers as well as review and update existing Quality Agreements with incumbent EM Suppliers. Identify and mitigate supplier quality and compliance risksIdentify supplier file gaps and work with EM suppliers to satisfy internal and external requirementsPerform supplier Onsite Assessment, Audits, For Cause audits and support new supplier due diligence activities as directed by managerProactivity manage and maintain supplier management files in order to be inspection ready at any given time.Support internal and external compliance audits as it relates to Supplier Quality Management activities.Proactively investigate, identify and implement best:in:class Supplier Quality Management practices.Assist supply chain and R and D organizations in sourcing new EM suppliers. Directly support management team for activities related to Management Review, Complaint Review Board and Critical Action Committee. The scope of this position is directly related to the Valeant North America External Manufacturing Supplier Quality Organization. The position has no supervisory responsibilities. The position will include routine interaction and communication with internal business stakeholders (Quality, Compliance, Supply Chain, R and D, Regulatory and Commercial) and external business partners (External Manufacturing groups). Internal Customers/Business Partners: Regulatory Affairs (NA)Research and DevelopmentGlobal Product Surveillance and SafetyPharmacovigilanceEMQA Quality EngineersEMQA Supplier AuditorsDesign Quality AssuranceCompliance Senior Leadership (NA)External Customers and Business Partners:External Manufacturing SuppliersEMEA Supplier QualityAudit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)Bachelor of Science degree in an engineering discipline (Mechanical, Biomedics, materials, Industrial, etc) or related technical field (microbiology, chemistry, etc) is required. Certification preferred by not required (such as CQA, CQE, CMQ/QE) Excellent communication skills (verbal and written). Ability to successfully influence others within project teams regarding quality or compliance concerns. Excellent organizations and presentation skills. Ability to hold people and functions accountable for resolving product quality issues, identifying root cause, implementing corrective and preventative actions and performing effective verification activities. A minimum of 6 years within a supplier quality organization (minimum 4 years in the Medical Device or Pharmaceutical industry is required). A MasterA?s degree in an engineering or technical related discipline may be substituted for two years of experience. Demonstrated expertise in Implementing and maintaining quality systems with emphasis in Supplier management cont

Source: https://www.tiptopjob.com/jobs/71577007_job.asp?source=backpage


• Location: Rochester

• Post ID: 30716802 rochester
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