Overview
Provide in-depth independent technical QA evaluations of manufacturer and supplier dossier submissions to support GDF’s product selection and procurement decisions. The consultant will assess whether submitted dossiers are complete, accurate, and compliant with GDF’s QA Policy and applicable regulatory standards.
Key Responsibilities
- Perform in-depth technical review of submitted QA documentation per product based on the GDF QA Policy.
- Check and verify the manufacturer’s QA and regulatory documents for compliance.
- Validate the authenticity and validity of ISO 13485/9001 or equivalent and other relevant certifications.
- Perform necessary technical due diligence on certifications and verification of accreditation status, including assessment of risks and implications.
- Confirm that certificates were issued by accredited notified bodies and are still valid.
- Draft and submit questions for clarification as needed.
- Assess any additional evidence submitted in response.
- Prepare comprehensive QA evaluation reports for each product reviewed, including risk assessments and formal recommendations.
- Provide technical advice to GDF management on quality assurance risks, regulatory compliance trends and related issues, as may be required.
- Deliver timely, high-quality technically sound QA evaluation reports for each assigned product submission, clearly documenting compliance with the GDF QA Policy, identified gaps or risks, and professional recommendations to accept, request additional information, or reject submissions.
- Prepare professional technical reports, well-structured clarification questions, assessments of follow-up evidence provided by suppliers, and accurate verification of the validity and authenticity of quality management system certifications.
Required Experience
- At least 5 years of experience in Quality Assurance for medical devices and/or other health products is required.
- Experience in in-vitro diagnostics and in applying relevant regulatory frameworks, including but not limited to IMDRF, WHO Prequalification, EU MDR 2017/745, EU IVDR 2017/746, FDA 21 CFR Part 820, or equivalent standards, is required.
- Proven track record evaluating products' QA submissions from manufacturers' dossiers is an asset.
- Experience in Compliance with Good Manufacturing Practices requirements for suppliers and manufacturers is an asset.
- Experience collaborating remotely with multicultural teams is an asset.
- Understanding of ISO 13485, ISO 14971, ISO 9001, MQAS and QMS audits for medical devices is an asset.
Qualifications
- A Master’s degree in pharmaceutical sciences, or biomedical engineering, or biological sciences, or a related field is required.
- A bachelor's with an additional 2 years of experience may be considered in lieu of a master’s degree.
