Quality Assurance Specialist

6 hours ago

Scottsdale, Arizona, United States Ziehm Orthoscan Full time
Quality Assurance Engineer

Ziehm Orthoscan Inc., a leading North Scottsdale Medical Device manufacturer, is seeking a highly motivated and career-oriented professional to fill the role of Quality Assurance Engineer. This is an exciting opportunity to join a dynamic team and contribute to the development and operation of quality control systems, testing, and metric tools to produce deliverable outcomes.

Key Responsibilities:
  • Assess, monitor, and report vendor and manufacturing quality data/statistics
  • Analyze quality data and develop strategic plans for improvement
  • Develop, implement, and oversee the effectiveness of supplier and manufacturing improvements
  • Review proposed changes (ECR/ECO), non-conforming material processing, and establish/maintain Quality System documents and records
Essential Functions:
  • Implement and maintain quality systems, policies, and procedures to ensure compliance with ISO 13485, cGMP, FDA, EU MDR, and other applicable standards
  • Collect, compile, analyze, and report quantitative and qualitative statistical quality data on suppliers and manufacturing
  • Track and communicate QA performance to the Quality Review Board and facilitate/support problem-solving, correction, and improvement activities
  • Support the QC Inspection team by planning, coordinating, and monitoring improvements, including creation/revision of documentation defining test methods and criteria
Requirements:
  • Bachelor's degree in Quality Engineering, Quality Assurance, Computer Science, Industrial Engineering, or related engineering degree
  • 5+ years of experience in a design and manufacturing medical device environment with emphasis on supplier and manufacturing quality assurance
  • 5+ years of experience in the application of LEAN, Six Sigma, SPC, or similar evaluation techniques to improve processes and performance
  • Demonstrated achievements in proactively seeking out and addressing product/process errors
  • Certification and experience in operating in and auditing quality systems certified under an accredited program
Desirable Skills and Competencies:
  • Ability to adapt and work efficiently in a rapidly changing dynamic environment
  • Excellent data analyzing and review/critical thinking skills
  • Effective project and time management skills
  • Ability to teach and mentor
  • Effective verbal and written communication skills
Working Conditions:

Work is performed onsite and in an office environment. Typical work schedule is Monday - Friday, 7-4pm, however, this is subject to change depending on work demands.

Prolonged periods of sitting at a desk and working on a computer. May require PPE and periodic exposure to low dose radiation.

We support a drug-free work environment. EOE/M/F/Disability/Vet

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