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Sr. Supply Chain Quality Engineer

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Company: Philips
Contract: PERM
Location: Home Based, United States


Job Title

Sr. Supply Chain Quality Engineer

Job Description

In this role, you have the opportunity to

promotes and implements organizational policies & standards to ensure product quality from design transfer to warehouse and distribution, including postponement/late customization, in compliance with regulatory requirements and Philips' Business Systems/procedures. 

You are responsible for

  • Ensure compliance with the Quality Management System, in accordance with Philips Policies and applicable worldwide regulations and standards. 
  • Facilitate development of and sustaining activities in support of core supply chain quality functions including nonconforming material management, acceptance activities, and general quality system functions for warehousing, distribution, manufacturing, and merge activities. 
  • Provide quality support to Integrated Warehousing and Distribution functions.
  • Support and Review where applicable Process Development, Validation, and Quality Controls throughout the lifecycle of supply chain products/solutions ensuring all necessary documents/records are maintained throughout the lifecycle of the product/solution.
  • Partner with Supplier Quality on processes related to the acquisition of purchased services, solutions, materials, components, sub-assemblies, and completed products and to ensure vendor assessments are completed
  • Lead and/or influence Productivity Programs and Critical process changes
  • Assist in the development and monitoring of QA and Supply Chain metrics.
  • Accountable for implementing and improving Supply Chain Quality Engineering capabilities supporting the supply chain.
  • Accountable for oversight of robustness of NPI and product transfers in supply chain locations.
  • Reports on projects status of new products or transfers to the supply chain site.
  • Accountable to ensure validation activities and employee capabilities to support validation and establishment of process controls.
  • Accountable to ensure appropriate Risk Management and Regulatory compliance is incorporated a crossed the supply chain
  • Responsible to establish Supply Chain quality systems and ensure they are maintained and documented.
  • Accountable for timely and appropriate quality documentation and records, and responsible for ensuring generation where applicable.
  • Accountable for ensuring timely review and approval of nonconforming records for nonconforming material within the warehouse and facilitating appropriate product dispositions partnering with business where necessary.
  • Responsible to champion lean initiatives, continuous improvement and complete QEKs, VSMs.
  • Provide Q&R oversight on Operations projects ensuring timely completion and appropriate quality of project deliverables.
  • Frequently interact with functional peers and upper management normally involving Supply Chain and operational matters between functional areas, other Business Groups / Units, or customers.
  • Seasoned experienced professional with a full understanding of manufacturing, distribution and operations, resolving a wide range of issues in creative ways, including the introduction of new concepts.
  • Wide-ranging experience within an engineering function.
  • Well versed in Quality Engineering and Continuous Improvement techniques.
  • Direct working relationships with suppliers preferred.
  • Participated in several NPIs from start to finish.
  • Prior experience in working in a manufacturing or warehouse related environment required.
  • Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), EU MDR, Japanese MHLW Ordinance 169, and ISO 9001.

To succeed in this role, you should have the following skills and experience

  • Bachelor degree in Engineering Science, or equivalent experience with > 5+ years of experience in a medical device or regulated industry.
  • A seasoned, experienced professional with a full understanding of Supply Chain operations related to warehouse, distribution, and manufacturing and quality system requirements.
  • Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company.
  • Often must lead a cooperative effort among members of a project team.
  • Strong knowledge of Design Transfer, Acceptance Activities, Production and Process Controls, and Supplier Quality Design Transfer activities. 
  • Excellent technical, writing and communication skills and interpersonal relationship skills including negotiating and relationship management skills.
  • Identifies technical gaps and takes action to address them.
  • Relentless focus on Product Quality as an organizational value.
  • Prior experience with large and complex quality continuous improvement programs and projects, with demonstrated success and impact on quality KPI’s.
  • Prior working experience with lean manufacturing practices with proven application in various manufacturing environments.
  • Data-driven decision-making and the ability to move teams through vague and complex situations to develop clearly defined programs.
 
 
 
 
 
 





More Info / Apply

(external link to recruiter web page)








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