This position is responsible for developing, defining, educating, advocating, and managing a superior compliance culture throughout Orthofix. Likewise, this position must ensure QS compliance with company quality system requirements as well as applicable standards and regulations. The position will report to the Director of Quality. This position is responsible for ensuring Orthofix management and employees are in compliance with the rules and regulations of regulatory agencies and that company policies and standard operating procedures are being followed.
What will your duties and responsibilities be?
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
- Ensures appropriate quality management system requirements have been effectively established and implemented to maintain compliance with US FDA's Quality System Regulation, the European Medical Device Directive, ISO13485, and other relevant domestic and/or international regulatory requirements.
- Executes Gap Analysis and/or Risk Assessments to ensure evaluation of key areas, such as manufacturing operations, laboratory and maintenance and engineering, are in compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, etc.
- Monitors completion of Post-Market activities, including complaint handling, to verify satisfaction of regulatory requirements, and manages or supports Recalls and Field Removals.
- Maintains awareness of regulatory landscape and takes appropriate steps to ensure continued QMS compliance.
- Ensures the Quality Policy and Manual have been effectively established, communicated, and implemented to maintain compliance with domestic and/or international regulatory requirements.
- Verifies CAPA's are implemented as required to maintain suitability of both products and the Quality System
- May provide training and/or training presentation documentation pertaining to FDA inspections, e.g. FDA hot topics, interaction with FDA officials, new regulatory approaches to inspections, etc.
- Ensures Quality Management System audits are planned, performed, results reported to executive management, and necessary / required corrective and/or preventive actions are taken in accordance with established procedures.
- Monitor risk management process, including post-production risk, to ensure all regulatory and compliance obligations are satisfied.
What skills and experience will you need?
- 15 years experience in a medical device industry
- Bachelor's degree and 6 years related quality systems, quality auditing, or regulatory compliance experience
- Knowledge of domestic and international medical device quality system laws, regulations and standards, such as 21CFR Part 820, ISO 13485:2016, ISO 14971, and ISO 11135.
- Excellent technical writing skill and ability to communicate well (both written and verbal) laterally and vertically.
- Project planning and management capability a must
- Computer knowledge: MS Word; MS Excel, MS Project,Visio, outlook, access, etc
- Logical cognitive skills and ability to apply scientific methods and/or systems thinking
- Ability to identify variables affecting all aspects of quality
- Ability to meet deadlines and/or objectives as directed
- Must be able to interpret device law into workable, efficient and effective practices and procedures.
- Lead auditor certification highly desired.