Manager, Quality Systems & Compliance - Purchasing Controls - Remote

Merck-posted 10 months ago
$94,300 - $148,500/Yr
Full-time • Manager
Rahway, NJ
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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 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 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.

  • 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.
  • Perform related duties, as assigned.
  • B.S. degree in an appropriate Science or Engineering discipline with a minimum of seven (7) years of experience with in-depth knowledge of pharmaceutical, medical devices and/or medical devices and combination products.
  • 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.
  • Bonus eligibility
  • Long term incentive if applicable
  • Health care and other insurance benefits (for employee and family)
  • Retirement benefits
  • Paid holidays
  • Vacation
  • Sick days
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