Postúlate en Kit Empleo: kitempleo.pe/empleo/wkcl4

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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.

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The Senior Quality

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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.

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Responsibilities

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- 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.
- Stay current with evolving medical device regulations and industry best practices.
- Perform other related duties as assigned.

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Qualifications

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- Bachelor's degree in Engineering (Biomedical, Mechanical, or related field) or equivalent.
- Minimum of 4-6 years of experience in quality engineering within the medical device industry, specifically with Class II devices.

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Experience with women's health or surgical products is a plus.

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- Thorough understanding of 21 CFR Part 820, ISO 13485, and other relevant medical device regulations and standards.
- Demonstrated experience in design control, risk management (ISO 14971), and verification and validation methodologies.
- Strong analytical and problem-solving skills, with the ability to identify and resolve quality issues effectively.
- Excellent communication (written and verbal)



and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Experience with statistical analysis tools and techniques.
- ASQ Certified Quality Engineer (CQE) preferred. Seniority level - Seniority level Mid-Senior level Employment type - Employment type Full-time Job function - Job function Quality Assurance, Engineering, and Administrative
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Postúlate en Kit Empleo: kitempleo.pe/empleo/wkcl4

📌 Senior Quality Engineer (Lima)
🏢 Biotalent
📍 Lima