Description

You will support manufacturing production and ensure adherence to procedures and device history record (DHR) documentation.

Responsibilities

• Support NC and CAPA processes by completing risk assessments, root cause investigations, and action plans.
• Review qualifications, validations, and studies for technical content, statistical rationale, and clarity.
• Participate in design transfer and improvement project teams.
• Implement and maintain Quality Management System effectiveness per ISO, FDA, and other regulatory requirements.

Required Skills

• Bachelor’s Degree in Engineering, Chemistry, Biotechnology, Life Science, or a related technical field.
• 1+ years of experience in the medical device or a regulated industry.
• Working knowledge of FDA, CGMPs/QSR, and ISO quality system requirements.
• Proficiency with database, internet, spreadsheet, and word processing software.
• Strong technical writing skills.
• Experience with CAPA processes.

Preferred Skills

• 2+ years of experience in the medical device or regulated industry.
• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification.
• Knowledge of Agile programs.

Key Skills

Education

Bachelor’s Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field