Manager, Quality Systems & Compliance - Purchasing Controls - Remote

Job Description

Position Overview - Basic Functions & Responsibility

As a member of the Medical Device Combination Products Quality QMS group, the Manager will participate in and/or lead various initiatives in support of oyr QMS Purchasing Controls and Device Supplier Management objectives and build QMS capabilities that touch every aspect of our business processes, systems, and data.

The Manager will collaborate and interact with cross-function teams to identify opportunities for improvement and tackle challenges, balancing effective operations with transformative initiatives. The Manager will report to the Associate Director, Quality System & Compliance and oversee the Device Supplier Management activities across MDCP programs and product lifecycle. Activities include supplier qualification & evaluation, documenting and maintenance of supplier quality agreements, supplier performance monitoring and re-evaluation, participating in supplier audits, and addressing any quality and regulatory issues. This role aims to ensure compliance with MDCP current Good Manufacturing Practices (cGMPs), other Global Health Authority Regulations and our company's requirements while driving continuous improvement in Device Supplier Quality Management.

Accountable for other Quality Programs, as assigned.

Primary Activities

Primary activities include, but are not limited to:

• 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.

• 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.

• Leads Quality/Compliance Risk Assessments including Quality Risk Management Plans, mitigation action plans (incoming inspection and final assembly processes) for MDCP suppliers.

• 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 QM Quality Standards and/or Global Procedures.

• Support MDCP sites with new/revised QMS QM Quality Standards and/or Global Procedures.

• Perform related duties, as assigned.

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