Quality Assurance Specialist

3 weeks ago


Scottsdale, Arizona, United States Ziehm Orthoscan Full time
Company Overview:

Ziehm Orthoscan Inc. is a renowned medical device manufacturer located in North Scottsdale, Arizona. As a full-time Quality Assurance Engineer, you will play a vital role in ensuring the development and operation of quality control systems that meet international standards. With a strong focus on supplier and manufacturing quality assurance, you will be responsible for assessing, monitoring, and reporting vendor and manufacturing quality data.

Estimated Salary: $90,000 - $110,000 per annum, depending on experience.

Job Description:

The successful candidate will implement and maintain quality systems, policies, and procedures that ensure compliance with ISO 13485, cGMP, FDA, EU MDR, and other applicable standards. Key responsibilities include collecting, compiling, analyzing, and reporting quantitative and qualitative statistical quality data on suppliers and manufacturing, recommending corrections and improvements. You will also track and communicate QA performance to the Quality Review Board and facilitate problem-solving, correction, and improvement activities. Additional duties include supporting the QC Inspection team by planning, coordinating, and monitoring improvements, creating and revising documentation defining test methods and criteria. The ideal candidate will have experience in operating in and auditing quality systems certified under an accredited program such as ISO9001, ISO13485, MDSAP, or EU MDR.

Required Skills and Qualifications:
  • 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.
  • Experience in application of LEAN, Six Sigma, SPC, or similar evaluation techniques to improve processes and performance, increase efficiency, reduce waste, reduce costs, and elevate product quality.

Benefits:
  • Competitive compensation package including estimated salary range.
  • Nine paid holidays plus a generous PTO and vacation time plan.
  • Great benefit plans, major medical, dental, and vision.
  • Company 401(k) plan with an employer match.

Others:

This role is subject to change based on work demands. The typical work schedule is Monday - Friday, 7-4pm. Please note that prolonged periods of sitting at a desk and working on a computer are required for this position. Ziehm Orthoscan supports a drug-free work environment and is an Equal Employment Opportunity (EEO) employer.



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