Quality Engineer

Kalamazoo, Michigan Quality Engineering 110 days ago

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Summary: Seeking a Quality Engineer with expertise in medical device OEM or contract manufacturing environments to develop and implement quality processes.

Requirements:

  • BS Degree in Biomedical or Manufacturing Engineering
  • 3-5 years' experience in a quality department within an ISO registered environment
  • Experience with ISO 13485 & ISO 9001 standards
  • Knowledge of process capability, production, equipment, and assembly effects
  • Proficiency in problem-solving methods (5Y, Fishbone, 8D)
  • Self-managed from a satellite operation

Preferred Skills:

  • Six Sigma certifications (green belt or higher)

Responsibilities:

  • Develop and implement quality processes for new programs and sustainment business
  • Involve directly in manufacturing process development and improvement
  • Resolve quality issues through root cause analysis and corrective actions
  • Implement preventative actions and continuous improvements
  • Manage non-conformance area including inventory disposition
  • Purchase and review gage equipment certifications and calibrations
  • Coordinate daily inspection, measurement, testing, and approval of components and products
  • Use quality management system software daily and conduct audits


Pay Details: $70,000.00 to $85,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance
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Equal Opportunity Employer/Veterans/Disabled
The Company will consider qualified applicants with arrest and conviction records.

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