Orthopedic Device Quality Assurance Specialist
5 days ago
We are seeking a highly skilled Orthopedic Device Quality Assurance Specialist to ensure the highest standards of quality and compliance within our organization. This role plays a pivotal part in establishing robust quality management systems (QMS) and regulatory strategies for product development, clinical trials, and manufacturing processes.
This is an exciting opportunity to work with a team of dedicated professionals who share your passion for quality and innovation. If you have a strong background in quality engineering and regulatory affairs, we encourage you to apply.
Key Responsibilities:- Develop, implement, and maintain QMS compliant with FDA Quality System Regulation ISO 13485:2016 and EU MDR 2017/745.
- Conduct risk assessments and failure mode and effects analysis (FMEA) to identify and mitigate potential issues in orthopedic device design and manufacturing.
- Oversee validation and verification of manufacturing processes and equipment ensuring design for manufacturability and product reliability.
- Perform quality control inspections reviewing specifications for raw materials, intermediate products, and finished orthopedic devices per engineering drawings and SOPs.
- Manage non-conformance investigations, root cause analysis, and corrective and preventive actions (CAPA) to address defects and ensure product safety.
- Interpret and ensure compliance with U.S. (FDA), EU (MDR), and international regulatory requirements for orthopedic medical devices.
- Support regulatory submissions including 510(k), PMA, and CE marking by preparing documentation and interfacing with regulatory authorities.
- Facilitate post-market surveillance including complaint investigations, trending complaint data, managing recalls, and medical device reporting to regulatory bodies.
- Coordinate internal and external audits ensuring readiness for regulatory inspections and supplier evaluations.
- Collaborate with R&D engineering and clinical development teams to integrate quality and regulatory requirements into the product development lifecycle from prototyping to commercialization.
- Work with suppliers to evaluate and certify their capabilities ensuring compliance with quality standards for materials used in orthopedic implants and devices.
- Provide regulatory guidance and training to internal teams to align with current standards and industry trends.
- Lead initiatives to reduce product recalls, defects, and associated costs by implementing effective QA processes.
- Monitor and update quality and regulatory documentation including Design History Files, Device Master Records, and Device History Records.
- Bachelor's or Master's degree in engineering, biology, chemistry, or related technical field.
- Minimum 8 years of experience in quality engineering or regulatory affairs within the medical device industry, preferably with orthopedic devices.
- Hands-on experience with FDA QSR, ISO 13485, ISO 14971, and EU MDR regulations.
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