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Base pay range

$110,000.00/yr - $120,000.00/yr

Direct message the job poster from BioTalent

Lead Regulatory, Quality and Clinical Affairs Recruiter, Medical Device & Diagnostics at BioTalent and Investigo, part of The IN Group

Job Summary:

We are seeking a highly motivated and experienced Senior Quality Engineer to join our team focused on developing and manufacturing Class II medical devices for women's surgical needs. The Senior Quality Engineer will play a critical role in ensuring the quality and compliance of our products, from design and development through manufacturing and post-market surveillance. This position requires a strong understanding of medical device regulations (21 CFR Part 820, ISO 13485) and a proven track record of successful quality system implementation and maintenance.

Responsibilities:
- Lead and execute quality system activities,



including internal audits, management review, corrective and preventive actions (CAPA), and document control.
- Develop and maintain quality system procedures and work instructions to ensure compliance with applicable regulations and standards.
- Support new product development projects by providing quality engineering expertise, including design control, risk management, and verification and validation activities.
- Collaborate with cross-functional teams (R&D;, Manufacturing, Regulatory Affairs) to ensure product quality throughout the product lifecycle.
- Conduct and oversee investigations of non-conformances and customer complaints, and implement effective corrective and preventive actions.
- Analyze quality data and trends to identify areas for improvement and drive continuous improvement initiatives.
- Participate in regulatory submissions and audits.
- Mentor and train other quality team members.
- St

📌 Senior Quality Engineer (Lima)
🏢 Biotalent
📍 Lima