Gentuity, LLC
This role will be responsible for ensuring the new products and design changes to existing products meet regulatory and quality requirements throughout the design and development process. This will be accomplished through collaboration with cross-functional teams performing verification and validation, process development activities, product risk management requirements and product reliability activities. The role also involves leading the sustainability efforts in production to ensure product compliance is maintained and ongoing process improvements are implemented.
Your Responsibilities Include Lead and support new product development design control deliverables for Catheter/Disposable or Software/Hardware products. Key opinion leader for the oversight over manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained. Lead Risk management activities including FMEAs (Process, Design, & Use), hazard analysis and other risk management file documents Maintains and audits Design History Files. Support the review and approval of Design Validation/Verification activities including IQ/CQ/MSA/OQ/PQ activities. Supports the generation and completion of protocols and reports for product, process, and test method validations. (IQ/CQ/MSA/OQ/PQ) Provide quality and compliance support during regulatory audits and responses to government agency questions. QA Lead for CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues (e.g., 5 whys 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. Participate in the design control and review processes, including quality planning. Perform quality driven statistical analysis. Lead activities for maintaining and updating standards across the design history file and product requirements. Lead the disposition of non-conforming materials meet all necessary regulatory requirements, support the investigation process and assure adequacy of corrective actions to prevent re-occurrence. Collaborates with Manufacturing Engineers to review processes for new and existing products and supports the coordinate of process validations and capability studies. Conduct Supplier Audits and investigations as needed. Supports and leads supplier qualification process. Lead the development of various inspection techniques and procedures to ensure product integrity to design specifications. Maintain and manage product risk management files. Support Post-Market Reporting activities for disposable products (e.g. Periodic Safety Update Report, Post Market Surveillance Reporting, and Post Market Clinical Follow-up Reporting) Support other projects or activities as assigned.
Experience / Qualifications Minimum of a bachelors degree in science, engineering, or other related technical discipline. 3 - 5 years of experience with engineering and development Proficient understanding in medical device design controls and risk management regulations such as ISO 13485, FDA 21 CFR 820.30, MDR (EU) 2017/745, ISO 14971, Knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required. Experience with statistical tools (i.e. Gage R&R, Capability Analysis, Anova, etc.) Proficiency in the use of root cause analysis tools (i.e. FMEA, Fishbone Diagram, 5 Why, 8D, etc.) Experience and demonstrated proficiency in Process Validation (IQ, OQ, PQ, TMV) Experience with catheter products or optical imaging technology preferred. ASQ Certified Quality Engineer (CQE), preferred. Able to effectively manage workload and deliverables. Ability to read and interpret drawings Excellent verbal and written communication skills. Thrives in a small size company and cross-functional team driven environment. A responsible team player that takes initiative and has a solution driven mindset. Detail oriented with strong organization skills Ability to work cross functionally and as part of a project team Self-Motivated and strong ability to adapt to change Experience with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
Your Responsibilities Include Lead and support new product development design control deliverables for Catheter/Disposable or Software/Hardware products. Key opinion leader for the oversight over manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained. Lead Risk management activities including FMEAs (Process, Design, & Use), hazard analysis and other risk management file documents Maintains and audits Design History Files. Support the review and approval of Design Validation/Verification activities including IQ/CQ/MSA/OQ/PQ activities. Supports the generation and completion of protocols and reports for product, process, and test method validations. (IQ/CQ/MSA/OQ/PQ) Provide quality and compliance support during regulatory audits and responses to government agency questions. QA Lead for CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues (e.g., 5 whys 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. Participate in the design control and review processes, including quality planning. Perform quality driven statistical analysis. Lead activities for maintaining and updating standards across the design history file and product requirements. Lead the disposition of non-conforming materials meet all necessary regulatory requirements, support the investigation process and assure adequacy of corrective actions to prevent re-occurrence. Collaborates with Manufacturing Engineers to review processes for new and existing products and supports the coordinate of process validations and capability studies. Conduct Supplier Audits and investigations as needed. Supports and leads supplier qualification process. Lead the development of various inspection techniques and procedures to ensure product integrity to design specifications. Maintain and manage product risk management files. Support Post-Market Reporting activities for disposable products (e.g. Periodic Safety Update Report, Post Market Surveillance Reporting, and Post Market Clinical Follow-up Reporting) Support other projects or activities as assigned.
Experience / Qualifications Minimum of a bachelors degree in science, engineering, or other related technical discipline. 3 - 5 years of experience with engineering and development Proficient understanding in medical device design controls and risk management regulations such as ISO 13485, FDA 21 CFR 820.30, MDR (EU) 2017/745, ISO 14971, Knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required. Experience with statistical tools (i.e. Gage R&R, Capability Analysis, Anova, etc.) Proficiency in the use of root cause analysis tools (i.e. FMEA, Fishbone Diagram, 5 Why, 8D, etc.) Experience and demonstrated proficiency in Process Validation (IQ, OQ, PQ, TMV) Experience with catheter products or optical imaging technology preferred. ASQ Certified Quality Engineer (CQE), preferred. Able to effectively manage workload and deliverables. Ability to read and interpret drawings Excellent verbal and written communication skills. Thrives in a small size company and cross-functional team driven environment. A responsible team player that takes initiative and has a solution driven mindset. Detail oriented with strong organization skills Ability to work cross functionally and as part of a project team Self-Motivated and strong ability to adapt to change Experience with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).