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Quality Assurance Specialist III

2 months ago

Boyne City, Michigan, United States Marmon Holdings, Inc. Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist III to join our team at Marmon Holdings, Inc. As a key member of our quality team, you will be responsible for ensuring the highest level of quality in our products and processes.

Key Responsibilities
  • Perform daily quality checks on products to ensure compliance with ISO 13485 and FDA QSR requirements
  • Use multiple measuring tools to verify product quality and accuracy
  • Communicate effectively with leaders and team members to ensure quality goals are met
  • Accurately document quality processes and procedures
  • Conduct internal audits and prepare for customer audits
  • Develop and execute verification and validation plans associated with product/process quality
  • Support supplier audits to ensure capability and evaluate proposed supplier process changes
  • Support quality planning as necessary for product, including risk analysis for new and legacy products
  • Perform hazard and risk analysis for new legacy products, including FMEA and decision tree analysis
  • Act as liaison between QC personnel and operations personnel to ensure inspection process capabilities have been verified and appropriately documented
  • Lead root cause analysis for customer complaints and internal product quality issues
  • Identify new inspection equipment to support production needs
  • Authorized to approve product realization (Quality Control) documentation in the absence of the Manufacturing and Quality Engineering Manager or Quality Manager
  • Develop and execute Measurement System Analysis
  • Mentor and develop Quality Department personnel
  • Train employees as needed
Requirements
  • BS in Engineering required
  • 8 + years' experience in quality engineering and/or
  • ASQ Certified Quality Engineer certification (preferred)
  • Supervisor or leadership experience (preferred)
Preferred Qualifications
  • Thorough understanding of current ISO 13485 and FDA QSR requirements and how they relate to Precision Edge
  • Advanced understanding of GD&T and metrology
  • Proficient in various software applications (i.e. Microsoft Office and Minitab preferred)
  • Must possess excellent documentation and technical writing capabilities
  • Independent self-starter who is capable of planning and managing multiple priorities
  • Ability to incorporate ASTM and ISO standards through the product life cycle, designing and developing the required inspection and process control methodologies
  • Must have excellent interpersonal skills, having the ability to interface with all levels of the organization, customers and suppliers
  • Thorough knowledge of analytical tools including Six Sigma, Lean and SPC
  • Ability to manage multiple projects simultaneously without supervision