Functions / Key Results Expected

• 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
• Data Security: Submissions may contain sensitive or proprietary information requiring the consultant to comply with GDF’s data handling and confidentiality policies.
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• The consultant is expected to 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. Outputs will also include 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. All outputs must be completed in accordance with GDF timelines, documentation standards, and data security and confidentiality requirements.
• Skills
• Analytical Skills, Corrective and Preventive Action, ISO 13485, ISO 9001, Quality Assurance, Regulatory Compliance, Report Writing, Teamwork, Detail-oriented

Competencies

• Develops and implements sustainable business strategies, thinks long term and externally in order to positively shape the organisation. Anticipates and perceives the impact and implications of future decisions and activities on other parts of the organisation.
• Treats all individuals with respect; responds sensitively to differences and encourages others to do the same. Upholds organisational and ethical norms. Maintains high standards of trustworthiness. Role model for diversity and inclusion.
• Acts as a positive role model contributing to the team spirit. Collaborates and supports the development of others. For people managers only: Acts as positive leadership role model, motivates, directs and inspires others to succeed, utilizing appropriate leadership styles.
• Demonstrates understanding of the impact of own role on all partners and always puts the end beneficiary first. Builds and maintains strong external relationships and is a competent partner for others (if relevant to the role).
• Efficiently establishes an appropriate course of action for self and/or others to accomplish a goal. Actions lead to total task accomplishment through concern for quality in all areas. Sees opportunities and takes the initiative to act on them. Understands that responsible use of resources maximizes our impact on our beneficiaries.
• Open to change and flexible in a fast paced environment. Effectively adapts own approach to suit changing circumstances or requirements. Reflects on experiences and modifies own behavior. Performance is consistent, even under pressure. Always pursues continuous improvements.
• Evaluates data and courses of action to reach logical, pragmatic decisions. Takes an unbiased, rational approach with calculated risks. Applies innovation and creativity to problem-solving.
• Expresses ideas or facts in a clear, concise and open manner. Communication indicates a consideration for the feelings and needs of others. Actively listens and proactively shares knowledge. Handles conflict effectively, by overcoming differences of opinion and finding common ground.

Education Requirements

Required

• 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.

Experience Requirements

Required

• 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