Quality Assurance Engineer (Expert Level)

• 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.

• 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.

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

Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.