JOB SUMMARY
Job type: Full time (hybrid working possible)
X-Bolt (based in Dublin) is an emerging innovator of orthopaedic devices that combines its patented expanding bolt technology with the most demanding needs in orthopaedic trauma. X-Bolt is dedicated to improving patient outcomes and providing innovative solutions to complex surgical challenges.
We are seeking an experienced Quality Assurance Manager with a deep understanding of quality systems and regulatory requirements for medical devices, with a proven track record of implementing and maintaining quality management systems to ensure compliance with ISO 13485 and FDA regulations. You will be working in the exciting early stages of X-Bolt’s commercialisation efforts.
If you are a strong leader, a natural problem solver, and driven to make an impact by advocating for our patients, this role may be for you!
KEY AREAS OF RESPONSIBILITY
- Implement a comprehensive quality management system in compliance with ISO 13485 and FDA regulations
- Ensure that all product design, development, and manufacturing activities comply with quality system requirements
- Participate in design control activities, including design reviews, risk management, and verification and validation activities
- Coordinate and manage supplier quality activities, including supplier selection, qualification, and performance monitoring
- Ensure that the corrective and preventive action (CAPA) system is effective and timely, including root cause analysis and implementation of corrective and preventive actions
- Manage and maintain all quality-related documentation, including procedures, work instructions, and records
- Establish and maintain quality metrics to measure the effectiveness of the quality management system.
QUALIFICATIONS
- Bachelor’s degree (Level 8) in engineering, science, or related field
- At least 3-years’ experience in a quality assurance role in the medical device industry
- In-depth knowledge of ISO 13485, ISO 9001 and/or 21 CFR 820 is required
- Experience in implementing and maintaining a quality management system
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team in a start-up environment
- Attention to detail and organisational skills are essential to this position.
Preferred qualifications
- Experience with FDA 510(k) submissions
- Experience with statistical process control and quality engineering tools
Please Contact
Phil Kemp
Chief Operating Officer
philip.kemp@x-bolt.com