Description

You will own IOQ, spreadsheet, PQ, TMV, and AQ validations while maintaining the quality management system to ensure regulatory compliance.

This role is remote.

Responsibilities

• Write and conduct IOQ and spreadsheet validations for medical devices.
• Execute complete PQ, TMV, and AQ validation protocols.
• Develop, monitor, and audit quality management system protocols and automation.
• Ensure all processes comply with CFR 21 Part 820 and ISO 13485 standards.

Required Skills

• Bachelor's degree in engineering (mechanical, electrical, chemical, bioengineering, or related).
• 5+ years of experience in the medical device industry.
• Proficiency in Microsoft Excel and computer programming.
• Working knowledge of CFR 21 Part 820 and ISO 13485.

Preferred Skills

• Experience with NPSV validations.
• Exposure to GAMP5 or similar regulations.
• ASQ Certified Quality Engineer (CQE) certification.

Key Skills

Education

Bachelor's degree