Senior Quality Engineer

BioTalent; Lima Metropolitana; Presencial; PEN 390.348 - 425.834; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

401(k)

Vision insurance

Paid maternity leave

Paid paternity leave

Descripción de la vacante

A leading company is seeking a highly motivated Senior Quality Engineer to ensure the quality and compliance of Class II medical devices. This role involves leading quality system activities, collaborating with teams, and mentoring junior staff. Candidates should have a strong understanding of medical device regulations and experience in quality engineering.

Formación

• 4-6 years of experience in quality engineering within the medical device industry.
• Thorough understanding of 21 CFR Part 820, ISO 13485.

Responsabilidades

• Lead quality system activities including audits and CAPA.
• Collaborate with cross-functional teams to ensure product quality.

Conocimientos

Analytical Skills

Problem Solving

Communication

Educación

Bachelor's degree in Engineering

Herramientas

Statistical Analysis Tools

Descripción del empleo

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This range is provided by BioTalent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

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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