Design Assurance Manager
3 weeks ago
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 an innovative, fast-paced global organization committed to improving transplantation outcomes. As part of our ongoing expansion, we seek a motivated Design Assurance Manager to join our team.
Job SummaryThe Design Assurance Manager will oversee quality efforts in support of our product development and design change activities, 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 engineering programs, policies, processes, procedures, and controls to ensure that product performance and quality meet established standards and agency regulations.
Key Responsibilities- Provide Design Assurance leadership, setting the vision and direction of Design Assurance Engineers.
- Direct the activities of the Design Assurance Engineers, growing the team to ensure delivery on business-critical compliance projects and design control.
- Offer expert-level guidance and direction of the Design Assurance Body of Knowledge.
- Create an inclusive learning environment with the QA Engineer team aligned to OrganOx values, mission & objectives.
- Align annually with the VP Quality and key stakeholders on workforce planning and talent management.
- Proactively assure compliance to all applicable internal, domestic, and international quality regulations, including US 21 CFR 820 (QSR), ISO 13485, etc., with a focus on design controls.
- Identify and manage activities related to risk reduction.
- Collaborate with key stakeholders to ensure effective management of budget.
- Represent the Design Assurance Function in the Product Development Management process, as applicable.
- Provide timely and evidence-based communication to the Management team, peers, and team.
- Foster continuous quality compliance and system/product improvements.
- Maintain evidence-based Quality Metrics and define and execute activities to meet these metrics.
- Be a champion of Quality, Six Sigma, and disciplined problem-solving throughout the organization.
- Assist in Design Assurance decision-making for key project analyses.
- 7+ years in quality desired with experience demonstrated in compliance excellence, design controls, and risk reduction.
- Class III or II medical device background.
- Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies required.
- Ability to travel as required for project efforts.
- Strong leadership skills with demonstrated ability to create momentum and deliver excellent results highly desired.
- Strong project management, team skills, and influential management also highly desired.
- Six Sigma Black Belt desired.
- Previous experience in managing engineering-level direct reports preferred.
A 4-year degree in bioscience, engineering, or equivalent or other related field.
BenefitsAt OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.
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Design Assurance Manager
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Oxford, Oxfordshire, United Kingdom OrganOx Full timeAbout OrganOx:OrganOx is a pioneering medical device company that has been revolutionizing organ transplantation since 2008. 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 improving transplantation outcomes. As a...
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Design Assurance Manager
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