Senior Quality Engineer
Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the care of patients suffering from a wide range of highly debilitating vascular diseases.
This role will be highly involved with the development and manufacturing activities to support new and existing medical device products. Involvement includes driving quality improvements as an integral part of the design and manufacturing process. This will be accomplished through participation in the quality engineering activities, verification and validation manufacturing activities, process development activities, product risk management requirements and product reliability.
Your Responsibilities Include
• Support new product development and sustaining manufacturing for medical device systems (hardware and software). (eg. EN 13485 / CFR820)
• Actively participate in risk management, PFMEAs, troubleshooting and root cause analysis for existing products per QMS and external standards. (e.g. EN 14971)
• Updates and maintains Design History Files.
• Provide quality and compliance support during regulatory audits and responses to government agency questions.
• Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
Responsible for the review and approval of manufacturing verification and validation protocols and test reports.
• Assist in the root cause investigation and corrective action for nonconforming material.
• Participate in design and manufacturing quality related issues.
• Participate in the design control and review processes, including quality planning.
• Perform quality driven statistical analysis.
• Perform other duties as assigned to support the advancement of the QMS and product manufacturing.
Experience / Qualifications
• Minimum of a bachelor’s degree in science, engineering, or other related technical discipline.
• Minimum of 5 years of experience in the medical devices industry.
• Subject matter expert in medical device design controls and risk management regulations (ISO 13485, FDA 21 CFR 820.30, MDR (EU) 2017/745/MDD, ISO 14971).
• Experience with capital equipment and product software as a medical device.
• Experience with intravascular catheters, preferred.
• ASQ Certified Quality Engineer (CQE), preferred.
• Able to effectively manage workload and deliverables.
• Excellent verbal and written communication skills.
• Thrives in a small size company and cross-functional team driven environment.
• Possess strong organization skills.
• Responsible team player that takes initiative and has a solution driven mindset.
• Experience with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent)
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