Support production on the manufacturing floor, ensuring adherence to procedures and ensuring appropriate device history record (DHR) documentation.
Support the NC and CAPA processes by completing risk assessments, root cause investigations, and action plans.
Reviews qualifications, validations, and other studies for technical content, statistical and sampling rationale, unintended impact and clarity.
May participate on design transfer and improvement project teams.
Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
May participate on design transfer and improvement project teams.
Basic Qualifications
Bachelor’s Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field and at least 1+ years’ experience in the medical device or other regulated industry.
Preferred Qualifications
2+ years’ experience in the medical device or other regulated industry.
Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) Certification
Knowledge of Agile programs. Working knowledge of Database software; Internet software; Spreadsheet software and Word Processing software.
Working knowledge of FDA, CGMPs/QSR and ISO quality system requirements. Strong technical writing.
Bachelor’s Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field and at least 1+ years’ experience in the medical device or other regulated industry.