Description

You will validate manufacturing processes and ensure strict adherence to device history record documentation and regulatory standards.

This role is on-site.

Responsibilities

• Support non-conformance and CAPA processes by conducting risk assessments and root cause investigations.
• Review qualifications, validations, and studies for technical accuracy and statistical rationale.
• Implement and maintain Quality Management System effectiveness per ISO and FDA requirements.
• Participate in design transfer and improvement project teams.

Required Skills

• Bachelor’s Degree in Engineering, Chemistry, Biotechnology, Life Science, or related technical field.
• 1+ years of experience in medical device or 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