A Quality Manager responsible for managing accessories delivered alongside a medical device under EU MDR 2017/745 must possess a specialized skill set to ensure compliance with regulatory requirements, maintain product quality, and support the safe use of the device and its accessories. Below are the essential skills and qualifications required:
Overall Experience :8-15yrs
1. Regulatory Knowledge:
- Understanding of EU MDR 2017/745: In-depth knowledge of the MDR and its application to medical devices and accessories, including Annexes and specific requirements related to accessories.
- Accessory Classification: Familiarity with how accessories are classified under the MDR (whether they are classified as a medical device or fall under other regulatory frameworks).
- Knowledge of Harmonized Standards: Knowledge of relevant European harmonized standards and guidelines that apply to medical devices and accessories (e.g., ISO 13485, ISO 14971).
2. Quality Management System (QMS) Expertise:
- ISO 13485 Compliance: Strong understanding of ISO 13485 requirements and its application to both medical devices and accessories, ensuring quality management systems are in place.
- Document Control & Change Management: Experience managing the documentation process, ensuring proper records, specifications, and design files for both the medical device and its accessories.
- Risk Management: Knowledge of ISO 14971 for risk management, specifically in the context of accessories and their role in the overall safety of the medical device.
3. Product Lifecycle Management:
- Design and Development: Ability to oversee the quality aspects of product design and development for accessories, ensuring compliance with regulatory requirements from concept to delivery.
- Post-Market Surveillance & Vigilance: Experience in setting up post-market surveillance systems for accessories, including reporting adverse events and ensuring continued compliance after the product is on the market.
- Clinical Evaluation: Understanding of clinical evaluation requirements for both medical devices and accessories, ensuring safety and performance criteria are met.
4. Supplier and Vendor Management:
- Supplier Qualification and Audits: Skills in qualifying suppliers for the accessories, ensuring they meet the necessary regulatory and quality standards.
- Supplier Quality Assurance: Managing quality expectations for external suppliers, especially if accessories are sourced from third-party vendors.
5. Cross-functional Collaboration:
- Collaboration with R&D and Design Teams: Ability to work closely with design and engineering teams to ensure quality is incorporated into the accessory's design from the start.
- Regulatory Affairs Coordination: Work with the regulatory affairs team to ensure accessories are compliant with applicable regulations before market release.
- Customer and Stakeholder Communication: Effective communication with internal stakeholders and customers about the accessory’s quality and regulatory status.
6. Training and Leadership:
- Team Leadership and Training: Ability to lead and train teams on the quality standards required for accessories, promoting a culture of quality.
- Internal Audits and Compliance Checks: Expertise in conducting internal audits to assess compliance with MDR and ISO standards for accessories, identifying areas for improvement.
7. Problem-Solving and Continuous Improvement:
- Root Cause Analysis: Expertise in identifying and analyzing quality issues related to accessories, utilizing tools such as CAPA (Corrective and Preventive Actions) and root cause analysis.
- Continuous Improvement: Driving a culture of continuous improvement, including the application of Lean, Six Sigma, or similar methodologies to optimize processes related to accessories.
8. Knowledge of EU Market Authorization:
- CE Marking for Accessories: Familiarity with the requirements and process for obtaining CE marking for accessories, including the necessary technical documentation, risk assessment, and clinical evaluations.
- Conformity Assessment Procedures: Knowledge of the conformity assessment process under the MDR for both the medical device and its accessories, including involvement of Notified Bodies if applicable.
- bodies, especially for post-market surveillance, vigilance, and compliance audits.
9. Language and Communication Skills:
- Multilingual Communication: If dealing with international suppliers or regulatory bodies, proficiency in relevant languages (e.g., English, German) would be beneficial for effective communication and documentation.
- Technical Writing Skills: Ability to create clear and concise technical documentation, including quality plans, reports, and regulatory submissions for accessories.
11. Software and Tools:
- QMS Software: Proficiency in using quality management software systems to track documentation, CAPAs, audits, and regulatory compliance.
- Risk Management Tools: Familiarity with risk management software tools to assess, mitigate, and document risks associated with accessories.
