Director of Quality Excellence
3 weeks ago
**About OrganOx**
">OrganOx is an innovative, fast-paced, global medical device company committed to improving transplantation outcomes worldwide. Our mission is to save lives by making every donated organ count.
The Director of Quality and Operations will play a critical role in ensuring that our products meet the highest standards of quality and safety. This includes developing and implementing quality assurance and engineering programs, policies, processes, procedures, and controls to ensure compliance with regulatory requirements.
Main Responsibilities:
- Provide overall Quality Engineering leadership, setting the vision and direction of Site Quality Managers and their teams
- Direct the activities of the Supplier Assurance Team, overseeing the activities of the Distribution Quality Team
- Offer expert-level guidance and direction of the Quality Engineering Body of Knowledge
- Create an inclusive learning environment within the Quality Team aligned to OrganOx Values and Mission
- Lead and define Quality organizational business deliverables in support of the Product Development Process
- Proactively identify opportunities to assure compliance to all applicable internal, domestic, and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
- Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility
- Communicate diligently and evidence-based communication to Executive Management team, peers, and team
- Assess resources needs to ensure the appropriate level of quality support is provided when needed with the competencies needed
- Oversee non-conformance and real-time data management portions of the Quality System
- Develop and continually improve a Supplier Management Program
- Champion post-production risk management activities, including complaint investigation, risk analysis, and action deployment to resolve any issues
Our ideal candidate has a strong background in quality, with at least 10 years of experience, including 3 years of management experience in demonstrated compliance excellence, value improvement, risk reduction, and cost containment. A Class III or II medical device background is required, as well as extensive experience with domestic and international regulatory requirements and regulating bodies. The ability to travel internationally to support supplier and manufacturing sites is also necessary.
Salary:** $120,000 - $180,000 per year **Benefits:** Comprehensive health insurance, 401(k) matching, paid time off, and professional development opportunities
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