Senior Quality Assurance Engineer

6 days ago


Durham, North Carolina, United States Baebies Full time
Job Overview

Baebies is a leading medical device company that develops and commercializes innovative newborn screening and near-patient testing products. Our mission is to enable early disease detection and comprehensive diagnosis, guided by the vision of providing a healthy start for all.

We are seeking an experienced Senior Quality Assurance Engineer to join our team in ensuring compliance with FDA, IVDD, IVDR, and ISO 13485 regulations. This role will be responsible for implementing and maintaining quality management system design and improvement activities to assure product quality and safety.

Key Responsibilities
  • Ensure compliance with regulatory requirements
  • Conduct internal audits and manage external audits
  • Develop and maintain corrective and preventive action systems
  • Administer non-conforming material and deviation processes
  • Support document control administration and employee training
  • Pre-Market Quality Assurance (Design and Process Documentation Review)
  • Provide support for equipment and process validation
  • Manage risk management processes throughout the product life cycle
  • Analyze and present QMS metrics


Requirements

The ideal candidate will have:
  • A Bachelor's degree in engineering or a life science field
  • At least 7 years of experience in Quality Assurance in the medical device industry
  • Familiarity with FDA and ISO 13485 quality systems regulations and guidelines
  • Experience with internal audits, product validation, and DHF requirements


Benefits

Baebies offers a dynamic work environment surrounded by intelligent and driven professionals. We provide competitive compensation, including a salary range of $80,000-$120,000/year, as well as a comprehensive benefits package, which includes 100% employee premiums for Medical & Vision coverage, 401K available, Stock Options, 4 Weeks PTO, Paid Holidays, and more.

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