Quality Assurance - IVDR
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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
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.
- 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.
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