Quality Assurance Engineer

About This Role

As a Quality Assurance Engineer, you will be responsible for validating and ensuring compliance with regulations and standards in the medical device industry. This role involves developing and auditing quality management systems to maintain high product quality.

Responsibilities

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

Requirements

• 5+ years of experience in the medical device industry
• Familiarity with CFR 21 Part 820
• Familiarity with ISO13485

Qualifications

• Bachelor’s degree in engineering (mechanical, electrical, chemical, bioengineering, or a related area)
• 5+ years of experience in the medical device industry

Nice to Have

• Knowledge of PQ, TMV, AQ, NPSV validations
• ASQ Certified Quality Engineer (CQE)

Skills

* Required skills