ABOUT ORGANOX:
OrganOx has been transforming organ transplantation since 2008, leveraging ground-breaking normothermic machine perfusion technology in our flagship product, the OrganOx metra. This technology helps preserve donor livers for up to 24 hours, in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion, we seek a motivated Design Assurance Manager to join our team.
Position Summary
The Design Assurance Manager oversees 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. Guided by our vision, we are dedicated to transforming transplantation and achieving our mission of saving lives by making every donor organ count.
In this position, the Manager will have decision-making responsibilities and be accountable for the accuracy and timeliness of those decisions. Reporting directly to the Vice President of Quality, the Manager will collaborate closely with the Research and Development, Manufacturing, and Post-Market Engineering departments to create a cooperative environment that encourages followership, teamwork, and adopts inclusive values on each member's contributions.
Major Responsibilities
1. Providing Design Assurance leadership including:
1. Setting the vision and direction of Design Assurance Engineers.
2. Directing the activities of the Design Assurance Engineers.
3. Growing the DA Engineers to ensure that the team delivers on business-critical compliance projects and design control.
4. Offering best-in-class expert level guidance and direction of the Design Assurance Body of Knowledge.
5. Creating an inclusive learning environment with the QA Engineer team aligned to OrganOx values, mission & objectives.
6. Aligning annually on workforce planning and talent management with the VP Quality and key stakeholders.
7. Proactively assuring compliance to all applicable internal, domestic, and international quality regulations (US 21 CFR 820 (QSR), ISO 13485, etc.), with focus on design controls.
8. Identifying and managing activities related to risk reduction.
9. Collaborating with key stakeholders to ensure effective management of budget.
10. Representing the Design Assurance Function in the Product Development Management process, as applicable.
11. Providing timely and evidence-based communication to the Management team, peers, and team.
12. Providing leadership and defining organizational activities in support of the Product Development Process.
13. Fostering continuous quality compliance and system/product improvements.
14. Maintaining evidence-based Quality Metrics and defining and executing activities to meet these metrics.
15. Being a champion of Quality, Six Sigma, and disciplined problem solving throughout the organization.
16. Assisting in Design Assurance decision making for key project analyses.
17. Other job duties as assigned.
Skills and Experience
* 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.
Qualifications
A 4-year degree in bioscience, engineering or equivalent or other related field.
At 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, colour, 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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