Quality Assurance Specialist

4 weeks ago


Reston, Virginia, United States EPM Scientific Full time

EPM Scientific is seeking a seasoned Quality Assurance professional to join our team on a 1-year contract basis for a Medical Device client. The successful candidate will play a pivotal role in ensuring the quality and compliance of our medical devices, collaborating closely with cross-functional teams to develop, implement, and maintain quality systems and processes that meet regulatory requirements and industry standards.

Key Responsibilities:

  • Develop and implement quality assurance protocols and procedures to ensure compliance with FDA regulations and ISO 13485.
  • Conduct risk assessments and failure mode and effects analysis (FMEA) to identify potential quality issues.
  • Perform root cause analysis and implement corrective and preventive actions (CAPA) to address quality deviations.
  • Collaborate with design and manufacturing teams to ensure product quality and compliance.
  • Review and approve design control documentation to ensure adherence to regulatory requirements.
  • Monitor and analyze quality metrics and trends to identify areas for improvement.
  • Provide training and support to staff on quality-related issues to ensure a culture of quality excellence.

Qualifications:

  • Bachelor's degree in Engineering, Life Sciences, or a related field.
  • Minimum of 3-5 years of experience in quality assurance within the medical device industry.
  • In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards.
  • Strong analytical and problem-solving skills, with excellent communication and interpersonal skills.
  • Proficiency in quality management software and tools, with certification in quality engineering (e.g., CQE) a plus.

What We Offer:

EPM Scientific offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to excellence and strive to provide the highest level of service to our clients and partners.



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