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Director, Design Quality Engineering

Director, Design Quality Engineering

FPC of Brighton
  • ,

FPC of Brighton

Director, Design Quality Engineering 

Remote Work Opportunity!|
Compensation: $150,000-$205,000 

Summary

Lead the design quality activities for a global Engineering Services organization.  Opportunity to own QMS development and integration within the well established product design teams.   

Responsibilities

  • Responsible for the Design, Deployment and support the engineering Quality Management System (QMS).
  • Oversee processes such as QMS, Customer Satisfaction Surveys, and Quality Excursion Reporting.
  • Provide leadership to the Design Assurance team across multiple design sites, ensuring compliance with standards and regulations.
  • Manage internal and external audits and partner design quality assessments.
  • Develop metrics for Design/Engineering quality performance and implement improvement strategies aligned with internal and customer goals.
  • Drive quality improvement initiatives and foster collaboration across the organization.
  • Develop and implement standardized quality protocols.
  • Lead and support compliance readiness to various customer regulatory standards and certifications (i.e., ISO9001, TL9001, AS9100, ISO13485, ANSI/ESD, ISO13485, IEC60601, IEC62304, etc.).

Requirements

  • 11 to 14 years of relevant experience.
  • Bachelor’s Degree in an Engineering field.
  • Experience owning or developing Quality Management Systems in highly regulated environment, particularly in Health-tech.
  • Practical product development and design experience.
  • Proficiency in Total Quality. Excellent knowledge of quality management systems and processes, including ISO 9001 and ISO 13485.
  • Understanding of electronic manufacturing environments and business processes.
  • Strong analytical, negotiation, and communication skills.
  • Ability to manage global resources and diverse teams.
  • Willingness to travel (~20%).

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