Description

You will manage quality compliance and technical documentation within a regulated manufacturing environment.

Responsibilities

• Support production on the manufacturing floor to ensure adherence to procedures and accurate device history record (DHR) documentation.
• Execute NC and CAPA processes by completing risk assessments, root cause investigations, and action plans.
• Review qualifications, validations, and technical studies for statistical rationale, sampling, and clarity.
• Contribute to design transfer and improvement project teams.
• Maintain the effectiveness of the Quality Management System in accordance with ISO and FDA 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 another regulated industry.
• Working knowledge of FDA, CGMPs/QSR, and ISO quality system requirements.
• Experience with NC and CAPA processes.
• Strong technical writing skills.
• Proficiency with database, internet, spreadsheet, and word processing software.

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 and at least 1+ years’ experience in the medical device or other regulated industry.