Quality Assurance Specialist

3 days ago


Minneapolis Minnesota, United States Cretex Medical Component and Device Technologies Full time
Job Summary

Cretex Medical Component and Device Technologies is seeking a highly skilled Quality Assurance Specialist to provide quality assurance support for manufacturing. This role is responsible for defining, implementing, and improving quality-related practices and providing technical guidance and measurement methodologies support.

Key Responsibilities
  • Provide quality engineering support for manufacturing and project management
  • Develop inspection requirements, facilitate PFMEAs, resolve discrepant material issues, and create and maintain quality documents such as control plans and inspection plans
  • Analyze data and identify improvement opportunities
  • Act as the quality interface for a production team in responding to customer complaints using failure analysis, development of corrective and preventative actions, and trend analysis
  • Conduct audits, including closing out audit findings, creating audit finding reports, and determining proper corrective and preventative actions
  • Lead and participate in intermediate company projects providing quality recommendations
  • Support validation activity of processes, equipment, and metrology
  • Create protocols and analyze data
  • Support the Quality Inspectors to ensure that inspection plans comply with the relevant requirements of customer's product requirements
  • Support and comply with the company Quality System, ISO, and medical device requirements
  • Read, understand, and follow work instructions and standard work
  • Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance
  • Understand customer needs and the core business markets we serve
  • Ensure business systems are implemented, maintained, and functioning properly
  • Participate in required company meetings
  • Maintain an organized work area (5S)
  • Participate in the Operational Excellence Program
  • Complete all other work duties as assigned
Requirements
  • Bachelor's Degree in Mechanical, Industrial, or in another Engineering Science
  • 3 years of experience in engineering in a machining or manufacturing setting
  • Knowledge of quality systems, regulatory requirements, and industry standards
  • Intermediate knowledge of blueprint reading and GD&T
  • Ability to operate a variety of inspection equipment
  • Statistical expertise with DOE and Capability Studies
  • Design software- Minitab
  • Process management
  • Ability to consistently achieve short and long-term business results
  • Experience with ERP and quality systems
  • Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
  • Clear and effective verbal and written communication skills
  • Attention to detail
  • Organizational skills
  • Ability to work in a fast-paced team environment
  • Ability to prioritize and multitask


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