Job Title: ISO 13485 Consultant
Deadline: 8th September, 2023
Job Summary:
We are seeking a highly skilled and experienced ISO 13485 Consultant to assist our medical diagnostic development and manufacturing social enterprise in achieving ISO 13485 certification. The consultant will play a critical role in guiding us through the certification process, ensuring that our quality management system aligns with international standards and best practices.
Responsibilities:
- Provide expert guidance and consultation on the implementation of ISO 13485 standards within our organization.
- Conduct thorough assessments of our current quality management practices and identify gaps in compliance with ISO 13485 requirements.
- Develop a comprehensive roadmap and action plan for achieving ISO 13485 certification within the specified timeframe.
- Collaborate with cross-functional teams to design and implement quality management processes, procedures, and documentation.
- Conduct training sessions to educate our staff on ISO 13485 requirements, processes, and their roles in maintaining compliance.
- Assist in the preparation of necessary documentation, including quality manuals, procedures, and work instructions.
- Conduct internal audits to evaluate the effectiveness of the quality management system and recommend improvements.
- Liaise with relevant regulatory bodies and certification agencies to ensure a smooth certification process.
- Monitor and track progress towards ISO 13485 certification milestones and provide regular status reports to management.
- Continuously update and adapt quality management practices to ensure ongoing compliance with ISO 13485 standards.
Requirements:
- Bachelor’s degree in a relevant field; advanced degree or certification in quality management is a plus.
- Proven experience as an ISO 13485 consultant or quality management professional in the medical device or diagnostic industry.
Experience:
- Track record of successfully guiding organizations to achieve ISO 13485 certification.
- Experience working with regulatory agencies and certification bodies is a plus.
Application
Please submit proposals and references to recruitment@wangaracapital.com by 8th September
