Quality Assurance Specialist

4 days ago


Fenton, Missouri, United States Corza Medical Full time
Quality Engineer Job Description

At Corza Medical, we are seeking a highly skilled Quality Engineer to join our team. As a Quality Engineer, you will play a critical role in ensuring the quality and safety of our medical devices.

Key Responsibilities:
  • Assist in the management of complaint handling systems, including intake, evaluation, and coordination of investigations.
  • Develop and present trending reports and regulatory reporting of device incidents.
  • Focus on improving, implementing, and maintaining quality systems in the manufacturing environment, including calibration, product inspection, and controls.
  • Assist in Material Review Board activities, ensuring proper trending, closure of issues, and dispositions are addressed.
  • Drive continuous improvement initiatives based on MRB data.
  • Support the development and maintenance of quality system documents and records, including Device Master Records, Technical Files, and QA System Release Records.
  • Support QA aspects of design and development of medical devices, including compilation, review, and approval of device design history files and risk management reports.
  • Define, develop, and manage quality projects and validation studies to ensure compliance with global regulatory requirements.
  • Assist in the management of supplier qualification and supplier oversight programs.
  • Perform external quality assessments as needed.
  • Support quality system audits and inspections performed by third parties, including EU Notified Body and regulatory authorities.
Requirements:
  • Minimum of 3 years' experience in direct engineering support of quality management systems for medical devices and manufacturing of sterile devices.
  • Working knowledge of FDA Quality System Regulation (21 CFR 820), EU Medical Devices Regulation (2017/745), and ISO 13485, ISO 14971, and ISO 11135.
  • Hands-on experience in quality system documentation.
  • Certified Quality Engineer (CQE) is a plus.
  • Bachelor's degree in an engineering discipline, preferably Mechanical Engineering.
What We Offer:

Corza Medical offers a competitive benefits package, including medical, 401K, vacation and sick time, paternal leave, and other benefits. We are an equal opportunity employer and evaluate qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status, or other protected characteristics.



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