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Quality Assurance - IVDR

Salary undisclosed

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Job Title: Quality Assurance - IVDR

Location: Middletown, VA

Duration: 12 months (with potential for extension) Job Description:

Overview: We are seeking a skilled Quality Assurance professional with expertise in In Vitro Diagnostic Regulation (IVDR) to join our team in Middletown, VA. The ideal candidate will play a critical role in ensuring that our diagnostic products meet the necessary regulatory standards and quality requirements.

Key Responsibilities

  • Develop, implement, and maintain quality assurance processes and procedures in compliance with IVDR.
  • Conduct regular audits and inspections to ensure adherence to regulatory standards and internal quality policies.
  • Collaborate with cross-functional teams to ensure product quality throughout the development lifecycle.
  • Review and approve quality documentation, including protocols, reports, and standard operating procedures (SOPs).
  • Identify areas for improvement within the quality management system and drive continuous improvement initiatives.
  • Assist in the preparation and submission of regulatory documents for IVDR compliance.
  • Provide training and support to staff on quality standards and regulatory requirements.
  • Investigate and resolve quality-related issues and non-conformances, ensuring proper corrective and preventive actions (CAPA) are taken.

Qualifications

  • Bachelor's degree in a relevant field (e.g., Life Sciences, Engineering, Quality Assurance).
  • Minimum of 4-8 years of experience in quality assurance within the medical device or in vitro diagnostics industry.
  • Strong knowledge of IVDR requirements and related regulatory standards.
  • Experience with quality management systems (QMS) and ISO standards (e.g., ISO 13485).
  • Excellent analytical and problem-solving skills.
  • Strong communication and interpersonal skills, with the ability to work collaboratively in a team environment.
  • Proficiency in Microsoft Office Suite and quality management software.