Associate Director, Device Supplier Management

* Works on all purchasing control phases for MDCP suppliers: planning, supplier evaluations/audits, supplier selection/qualification, quality agreements, supplier monitoring and re-evaluation, maintenance, and sustainability.* Develop and implement phase‐appropriate supplier controls for early commercialization to effectively support MDCP programs in Development.* Supports Supplier Audits, as Medical Device SME.* Partner with MDCP sites and internal stakeholders to support investigations related to supplier caused deviations and CAPAs.* Integrate Purchasing Control Activities into Integrated Project Plan for each MDCP Program (with target dates) for execution.* Support the development of our company's supplier device specification based on intended use and user needs which includes defining list of requirements needed to be specified to supplier (quality, technical, commercial, supply) - shelf life, critical attributes, essential performance requirements, etc.* Collaborate with Procurement for Device components, medical devices, and MDCPs to ensure all cGMP Purchasing Controls requirements are compliant.* Participates on our teams supporting MDCP cGMP and quality issues related to pure Medical Devices and the device constituent part of a Combination Product.* Manage activities within electronic computer systems, e.g., Material Management Systems (SAP), Document Management Systems (Veeva Vault), Supplier Management Systems, etc.* Support MDCP sites with new/revised QMS Quality Standards and/or Global Procedures.* Perform related duties, as assigned.* Preferred experience in the assessment of US FDA 21 CFR Part 4 and Part 820, EU MDR:2017/745, and ISO 13485:2016 for review of Quality Management System documents for the Quality Manual.* Previous experience in Medical Device and/or Medical Device Combination Products E2E Supplier Quality Management activities and preferred supplier auditing experience.* Must have strong knowledge of regulations listed above and be able to work in a team environment identifying gaps in the QMS documents.* Working knowledge for the design, manufacture, packaging, purchasing, testing, release, storage, and distribution of medical devices and/or medical device combination products.* Must be able to build relationships within a team environment.* Experience using computer systems for Quality Management Systems.* Must have working knowledge of regulatory expectations for the design, manufacture/packaging and distribution of medical devices or medical device combination products with experience in quality assurance or regulatory oversight of these products.* Experience authoring, reviewing and approving Quality Management System documents.* Solid organizational skills including attention to detail and multi-tasking skills.* Effective people skills and ability to work collaboratively across diverse teams and networks, able to foster cooperation in others.* Effective written and oral communicator, ability to speak up and contribute in a team forum.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr