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

Qualifications:

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

Medical Equipment Manufacturing, Engineering Services, and Biotechnology Research

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Inferred from the description for this job

Medical insurance

401(k)

Vision insurance

Paid maternity leave

Paid paternity leave

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📌 Senior Quality Engineer (Lima)
🏢 Biotalent
📍 Lima