Quality Assurance Engineer

1 month ago


Birmingham, United States LHH Full time

The successful candidate will significantly influence the company's compliance with quality system regulations and standards, particularly in evidence-based and scientifically-proven product areas such as product inspection, engineering design controls, and design change controls.


Responsibilities

  • Investigating and supporting individual customer product complaints by summarizing and reporting results.
  • Ensuring compliance with the Quality System through policy establishment and controlled documents.
  • Conducting Process Validations, including necessary risk management activities.
  • Managing nonconforming material and supporting daily Material Review Board (MRB) activities.
  • Providing support to New Product Development (NPD) teams regarding 21 CFR Part 820, Part 1271, and associated EU/Canadian standards.
  • Establishing, documenting, and maintaining the company's document control system, including change control and record-keeping.
  • Assisting Research & Development with reviewing and approving design inputs.
  • Overseeing regulatory and manufacturing standard reviews to ensure State of the Art compliance.
  • Documenting, releasing, and communicating changes to company supplier quality assurance policies and procedures.


Qualifications

  • 2 years in FDA-regulated environment with technical specs and documentation.
  • Proficient in Microsoft Windows and Office applications.
  • Excellent reading, writing, and verbal communication skills.
  • Knowledge of regulatory medical device and international quality standards desired.
  • Professional interaction with colleagues and suppliers.
  • Experience with Electronic Quality Management System software (e.g., ETQ Reliance) desired.
  • Bachelor's degree preferred or equivalent experience.
  • ASQ Certified Quality Engineer certification preferred.



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