Senior Orthopedic Medical Device QA Professional
6 hours ago
Medical Device Quality Assurance Specialist
Our team is responsible for advancing global orthopedic solutions that improve patient outcomes. We strive to develop and implement robust quality management systems (QMS) compliant with FDA Quality System Regulation (QSR), ISO 13485, and EU MDR regulations to support product development, clinical trials, and manufacturing processes.
Key Responsibilities:
- Develop, implement, and maintain quality assurance processes to ensure compliance with regulatory requirements.
- Conduct risk assessments and failure mode and effects analysis to identify and mitigate potential issues in orthopedic device design and manufacturing.
- Oversee validation and verification of manufacturing processes and equipment to ensure design for manufacturability and product reliability.
- Perform quality control inspections reviewing specifications for raw materials, intermediate products, and finished orthopedic devices.
- Manage non-conformance investigations, root cause analysis, and corrective and preventive actions to address defects and ensure product safety.
Regulatory Compliance:
- Interpret and ensure compliance with U.S. and EU regulatory requirements for orthopedic medical devices.
- Support regulatory submissions preparing documentation and interfacing with regulatory authorities.
- Facilitate post-market surveillance including complaint investigations, trending complaint data, and managing recalls.
Cross-Functional Collaboration:
- Collaborate with R&D, engineering, and clinical development teams integrating quality and regulatory requirements into the product development lifecycle.
- Work with suppliers to evaluate and certify their capabilities ensuring compliance with quality standards.
Continuous Improvement:
- Lead initiatives to reduce product recalls, defects, and associated costs by implementing effective QA processes.
Qualifications: Bachelor's or Master's degree in engineering, biology, chemistry, or a related field. Minimum 8 years of experience in quality assurance or regulatory affairs within the medical device industry preferably with orthopedic devices.
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