Director of Quality Operations
4 weeks ago
OrganOx is a pioneering medical device company dedicated to revolutionizing organ transplantation. We are seeking a highly skilled Director, Operations Quality, to lead our quality efforts and ensure the highest standards of product performance and quality.
Key Responsibilities:- Develop and implement quality assurance and engineering programs, policies, processes, procedures, and controls to meet established standards and agency regulations.
- Provide leadership and guidance to Site Quality Managers and their teams, ensuring a cooperative environment that encourages teamwork and values each member's contributions.
- Oversee the activities of the Distribution Quality Team and 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, identifying opportunities to assure compliance to all applicable internal, domestic, and international quality regulations.
- 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 assure that the appropriate level of quality support is provided when needed with the competencies needed.
- Oversee the non-conformance and real-time data management portions of the Quality System, developing and continually improving a Supplier Management Program.
- Champion post-production risk management activities to include complaint investigation, risk analysis, and action deployment to resolve any issues.
The ideal candidate will have 10+ years in quality, with at least 3 years of management experience in demonstrated compliance excellence, value improvement, risk reduction, and cost containment. A Class III or II medical device background and extensive experience with domestic and international regulatory requirements and regulating bodies are required. Ability to travel internationally to support supplier and manufacturing sites is also necessary. A 4-year degree in bioscience, engineering, or equivalent is preferred.
OrganOx is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment that values each member's contributions.
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Quality Operations Director
2 weeks ago
Oxford, Oxfordshire, United Kingdom Skills Alliance Full time**Job Title:** Director, Quality OperationsWe are seeking a highly skilled Director of Quality Operations to oversee our quality efforts from suppliers to product distribution, in line with our core values of innovation, evidence, integrity, teamwork, respect, and a commitment to transplantation.This critical role is responsible for developing, establishing,...
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Quality Director
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Oxford, Oxfordshire, United Kingdom OrganOx Full timeDirector, Operations QualityOrganOx seeks a skilled Director, Operations Quality to oversee quality efforts from suppliers to product distribution, reflecting our core values of innovation, evidence, integrity, teamwork, respect, and a commitment to transplantation.This role is crucial in developing, establishing, and maintaining quality assurance and...
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Oxford, Oxfordshire, United Kingdom OrganOx Full timeAbout OrganOx: A Global Leader in Medical Device InnovationWe are seeking an experienced Operations Director to lead our quality and compliance efforts, reflecting our core values of innovation, evidence, integrity, teamwork, respect, and a commitment to transplantation.The successful candidate will oversee quality assurance and engineering programs,...
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Operations Quality Director
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Oxford, Oxfordshire, United Kingdom OrganOx Full timeAbout OrganOx:We are a pioneering medical device company dedicated to transforming organ transplantation. Our flagship product, the OrganOx metra, utilizes groundbreaking normothermic machine perfusion technology to preserve donor livers for up to 24 hours, reducing organ discard rates and facilitating more successful transplants.Job Summary:We are seeking a...
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Operations Quality Director
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Oxford, Oxfordshire, United Kingdom OrganOx Full timeAbout OrganOx:OrganOx is a pioneering medical device company dedicated to transforming organ transplantation. Our flagship product, the OrganOx metra, utilizes groundbreaking normothermic machine perfusion technology to preserve donor livers for up to 24 hours, reducing organ discard rates and facilitating more successful transplants. We are a fast-paced,...
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