Senior Supplier Quality Engineer

PUB362710

工作内容: Senior Supplier Quality Engineer

Introduction

Our client is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. Their portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care.

  • Create and maintain strong relationships and effective lines of communication with Suppliers
  • Develop partnerships across multiple facilities with Supply Chain, R&D, Design Assurance, and Manufacturing groups
  • Lead the investigation, resolution, and prevention of supplied component nonconformances
  • Trend data, identify improvement projects, and implement improvements (increase capability, reduce scrap, improve/repair processes, etc.) at company and at Supplier to improve quality and supplier performance
  • Initiate and follow-up Supplier Corrective Actions (SCARs) in partnership with impacted cross-functional groups to ensure complete and effective root cause analysis and corrective action implementation
  • Perform periodic audits of Supplier quality systems to assure continued Supplier conformance to the quality system requirements
  • Manage, review, and approve Supplier change requests and partner with Sustaining Engineering, Regulatory, and Supply Chain to develop and implement appropriate strategies to support qualification through the change approval process
  • Recommend and drive continuous improvements in the Supplier Quality organization, to improve the related systems and processes
  • Prepare and negotiate Quality Agreements with Suppliers
  • Assess potential new Suppliers for technical, quality, and manufacturing capabilities
  • Lead cross-functional projects with concise and clear plans that consistently hit project milestones, as well as develop strong contingency plans as part of the project planning process
  • Collaborate with Suppliers to develop comprehensive process-validation strategies
  • Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Initiate and lead change orders, deviations, and investigations to maintain compliance

职位要求

  • BA/BS in Engineering or physical sciences
  • 5 years of related experience
  • Self-starter with the ability to quickly learn about new processes, projects, and requirements
  • Ability to leverage, influence and/or engage others to accomplish projects
  • Strong verbal and written communication skills, including the ability to write technical reports / presentations and to negotiate Supplier Quality Agreements
  • Solid organizational and follow-up skills, as well as attention to detail
  • Critical thinker with analytical problem-solving skills, able to resolve quality-related issues in a timely and effective manner
  • Knowledge of quality-related tools including, but not limited to, SPC, DOE, TMV, and Quality Systems
  • Experience with various process-improvement methodologies, such as Six Sigma and Lean Manufacturing
  • Working knowledge of US and international medical device regulations, standards and guidance documents. Including:
    • 21 CFR 820 US FDA Quality System Regulations
    • ISO 13485:2016 Medical Devices – QMS – Requirements for Regulatory Purpose
    • MDD 93/42/EEC Medical Device Directive (European)
    • Regulation (EU) 2017/745 Medical Device Regulations
  • ISO 13485:2016 Lead Auditor Certified, or similar Lead Auditor certification (ASQ CQA, for example)

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PUB362710

Account manager

Max Schumacher
Brunel USA - Minneapolis
m.schumacher@brunel.net

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