Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.
About the Role
As the Director, Device Quality Engineer, you will be responsible for oversight of our combination product design team and have direct impact on the overall success of our device development along with the engineering teams.
Reporting to the Head of Quality, you will be the sole device Quality Engineer and will play a crucial role in ensuring the quality and safety of our combination products, with a focus on autoinjectors. Day to day, you will work closely with our device development leader and other cross-functional teams to help oversee vendors for end-to-end product development lifecycle. You will be an active member of the project team, fostering engineering best practices, and maintaining project goals that will improve patientâs lives. You must have experience as a lead design quality engineer, with specific experience as part of an auto-injector design team.
This is a unique opportunity to join a growing organization and have a significant impact on our combination product development. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patientsâ lives. We are open to you working remotely.
- Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance to applicable regulations, guidanceâs, or compendia.
- Participate in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.
- Lead or co-audit on device vendor audits in support of vendor qualification including preparation of audit agenda, audit report, and follow-up with vendor on corrective actions.
- Actively participate in routine (e.g. weekly) meetings with device vendors and consultants to support project milestones.
- Execute the phases of Design Controls during product development.
- Support regulatory audits as a Subject Matter Expert for Design Controls and other aspects of the quality system.
- Support and ensure internal & external audit responses and on-time product re-certifications.
- Additional duties may be identified by functional management based on current project/business objectives.
- Ensures that outputs comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Support initiatives as identified by management and in support of the Quality Management Systems (QMS), and other regulatory requirements.
- Bachelor's degree Engineering
- Experience in Design Quality Engineering, with a focus on combination products. Autoinjector development experience is a plus.
- Strong knowledge of regulatory requirements for combination products, including ISO 13485, ISO 14971, ISO 11608, 21 CFR Part 820, EU MDR, ISO 14644, and ability to interpret applicability to Dianthusâs application.
- Strong capability to perform risk analysis and facilitate cross-functional risk analysis meetings.
- Utilize quality tools including Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.
- Ability to lead root cause analysis investigations (Fishbone/Ishikawa diagrams, etc.)
- Deep understanding of Design Control, Process Validation (IQ/OQ/PQ) and Verification Testing, Test Method Validation & Statistical Techniques
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.,
- Detail-oriented with a focus on continuous improvement and innovation.
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