Description

• Write and conduct IOQ and spreadsheet validations.
• Complete PQ, TMV, AQ validations.
• Develop, maintain, monitor, and audit quality management system and protocols, including systems automation, processes, and procedures that ensure compliance with regulations and standards.

The essential requirements of the job include:

• Bachelor's degree in engineering (mechanical, electrical, chemical, bioengineering, or a related area) and 5+ years of experience in the medical device industry.
• Familiarity with CFR 21 Part 820 and ISO13485.
• Proficiency in Microsoft Excel and a good working knowledge of computer programming and systems.

It would be a plus if you also possess previous experience in:

• Knowledge of PQ, TMV, AQ, NPSV validations.
• Exposure to Gamp5 or similar regulations.
• ASQ Certified Quality Engineer (CQE)

Key Skills

Education

Bachelor's degree