Design Assurance Manager

at  OrganOx

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.
Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

Under direction from the Vice President, Quality, the Manager, Design Assurance will be responsible for:

• Providing Design Assurance leadership including:
• Setting the vision and direction of Design Assurance Engineers.
• Direct the activities of the Design Assurance Engineers.
• Grow the DA Engineers to ensure that the team deliver on business-critical compliance projects and design control.
• Offers best in class 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.
• With the VP Quality and key stakeholders, align annually on workforce planning and talent management.
• Proactively assure compliance to all applicable internal, domestic and international quality regulations:

US 21 CFR 820 (QSR), ISO 13485, etc., with focus on design controls

• Identify and manage activities related to risk reduction
• Collaborating 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.
• Provide leadership and define organizational activities in support of the Product Development Process.
• 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.
• 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.

• Providing Design Assurance leadership including:
• Setting the vision and direction of Design Assurance Engineers.
• Direct the activities of the Design Assurance Engineers.
• Grow the DA Engineers to ensure that the team deliver on business-critical compliance projects and design control.
• Offers best in class 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.
• With the VP Quality and key stakeholders, align annually on workforce planning and talent management.
• Proactively assure compliance to all applicable internal, domestic and international quality regulations