Product Quality Assurance Specialist

4 weeks ago


Reston, Virginia, United States BioTalent Full time

Job Title: Quality Engineer

About the Role: BioTalent is seeking a skilled Quality Engineer to support the development and production of structural heart implants, delivery systems, and robotic devices.

Key Responsibilities:

  1. Conduct quality monitoring during production, ensuring compliance with GMP regulations and internal quality standards.
  2. Lead investigations into nonconformances, conduct root cause analysis, and implement corrective actions.
  3. Develop and execute process validation protocols, including IQ/OQ/PQ.
  4. Collaborate with cross-functional teams to resolve quality issues and drive process improvements.
  5. Perform audits and inspections to identify quality enhancements.
  6. Oversee biocompatibility and sterilization processes, coordinating with R&D and third-party providers.
  7. Ensure proper packaging validation and finished goods release.
  8. Maintain accurate documentation and support regulatory compliance.
  9. Participate in internal and external audits.

Requirements:

  • Bachelor's in Engineering or a related field; Master's preferred.
  • 7+ years of experience in manufacturing quality engineering in the medical device industry.
  • Familiarity with FDA regulations, ISO 13485, and cleanroom environments.
  • Experience with CAPA processes and certifications is a plus.


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