Senior Quality Assurance Specialist

hace 6 días


Tijuana, Baja California, México Buscojobs México A tiempo completo

About Us

We are a leading company in the medical device industry, dedicated to providing high-quality products and services. Our team is passionate about delivering exceptional results and making a positive impact on people's lives.

Job Description

We are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring the quality of our products and processes, identifying and implementing improvements, and maintaining compliance with regulatory requirements.

Key Responsibilities:

  • Assist the Q.A. Manager in developing, documenting, and implementing quality system procedures and records.
  • Perform routine internal quality system audits and supplier audits to ensure compliance with procedures.
  • Report audit findings to management and participate in CAPA activities to determine corrective actions.
  • Lead or participate in project transfers and process controls to establish acceptance criteria for products.
  • Maintain accurate records and reports related to quality assurance activities.

Requirements:

  • Bachelor's degree in Engineering or a technical discipline.
  • Formal education or training in quality assurance techniques, including quality system auditing, statistical tools, design of experiments, regression analysis, and statistical sampling methods.
  • Two+ years of experience in manufacturing operations desirable.
  • Experience in medical device regulations and standards, including FDA's medical device regulations under Title 21 CFR Part 820 and European Medical Device Directive 93/42/EEC.

Benefits:

  • A competitive salary and benefits package.
  • The opportunity to work with a dynamic and collaborative team.
  • A comprehensive training program to support your professional growth and development.
  • A safe and healthy work environment.


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