Job Duties

• 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.