Quality Assurance Engineer

6 days ago


New York, New York, United States Extremity Care Full time
Job Title: Quality Systems Engineer

At Extremity Care, we are seeking a highly skilled Quality Systems Engineer to join our team. As a Quality Systems Engineer, you will play a critical role in ensuring the quality and compliance of our products and processes.

Key Responsibilities:
  • Develop and implement quality systems and processes to ensure compliance with regulatory requirements.
  • Support new product development activities, including the development of Master Validation Plans, PFMEA's, Control Plans, and Procedure and Process development.
  • Investigate and resolve quality events, including NCs and CAPAs.
  • Own applicable quality systems related NC/CAPA's and maintain current knowledge of FDA QSR, FDA 21 CFR 1271, ISO 13485, AATB Standards, and DMEPOS requirements.
  • Analyze inspection and testing processes, mechanisms, and equipment.
  • Develop and/or review product, process test equipment and/or software validation and qualification protocols and track execution of protocols in support of project timelines.
  • Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
Requirements:
  • A minimum of a bachelor's degree in science, engineering, or other relevant discipline.
  • A minimum of 3 years of experience working in an FDA or ISO regulated environment.
  • A minimum of 3 years of supervisory experience or equivalent.
What We Offer:
  • A dynamic and challenging work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.


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