Quality Assurance Specialist Medical Devices

4 weeks ago


Miami, Florida, United States Actalent Full time

Job Summary

The Staff Quality Engineer is responsible for providing quality engineering support, with a focus on post-market activities. This includes working with manufacturing, R&D, Marketing, Sales, and other Quality functions to address post-market feedback. The ideal candidate will develop, modify, apply, and maintain quality standards.

Key Responsibilities

  • Stop non-conforming processing, shipments, and manufacturing, and escalate to Quality Management and/or Executive Management.
  • Apply and understand statistical methodologies for conformity assessment and investigative activities.

Requirements

  • Bachelor's Degree in Engineering, Science, or a technical field.
  • 5+ years of work experience in Engineering and/or Quality.

Preferred Qualifications

  • Expertise in medical device recalls per 21 CFR 806 and other applicable standards.
  • Proficiency in Quality Management Systems (QMS), 21 CFR 820, and ISO 13485 standards.
  • Expertise in ISO 14971 and internal risk management processes.
  • Expertise in complaint assessment and handling per 21 CFR 820.

About Actalent

Actalent is a company that helps visionary companies advance their engineering and science initiatives. We provide access to specialized experts who drive scale, innovation, and speed to market. With a network of almost 30,000 consultants and over 4,500 clients across the US, Canada, Asia, and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. We build a culture of care, engagement, and recognition with clear outcomes.

Equal Opportunity Employer

Actalent is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.



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