Associate Director, Quality Systems & Compliance - Purchasing Controls

Job Description

Position Overview Basic Functions & Responsibility

As a member of the Device Quality & Regulatory QMS group the Associate Director will participate in and/or lead various initiatives in support of our QMS Purchasing Controls and Device Supplier Management objectives and build QMS capabilities that touch every aspect of our business processes systems and data.

The Associate Director will collaborate and interact with crossfunction teams to identify opportunities for improvement and tackle challenges balancing effective operations with transformative initiatives. The Associate Director Quality System & Compliance will support to integrate 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 reevaluation 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 companys 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 reevaluation 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 companys 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.

Skills

• 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 multitasking 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.

Qualifications:

• B.S. in an appropriate Science or Engineering discipline with a minimum of 8 years of experience with indepth knowledge of pharmaceutical medical devices and/or medical devices and combination products with at least 4 years in Supplier Quality Management System/ Purchasing Controls and in managing external partners / suppliers.

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Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

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Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.

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