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 as it relates to Software and Hardware products.
Your Responsibilities Include
Lead and support new product development design control deliverables for Software/Hardware products.
Lead Risk management activities including FMEAs, hazard analysis and other risk management file documents.
Maintains and audits Design History Files.
Support Process/Design Validation/Verification activities including IQ/CQ/MSA/OQ/PQ activities.
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 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.
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 new supplier qualification activities for hardware and software components.
Support obsolescence and design changes for hardware components in production.
QA Lead on the Software Review Committee.
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 bachelor’s 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 Software development cycle.
ASQ Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE), 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.
A responsible team player that takes initiative and has a solution driven mindset.
Experience with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Engineering and Information Technology
Industries
Medical Equipment Manufacturing
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Your Responsibilities Include
Lead and support new product development design control deliverables for Software/Hardware products.
Lead Risk management activities including FMEAs, hazard analysis and other risk management file documents.
Maintains and audits Design History Files.
Support Process/Design Validation/Verification activities including IQ/CQ/MSA/OQ/PQ activities.
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 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.
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 new supplier qualification activities for hardware and software components.
Support obsolescence and design changes for hardware components in production.
QA Lead on the Software Review Committee.
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 bachelor’s 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 Software development cycle.
ASQ Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE), 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.
A responsible team player that takes initiative and has a solution driven mindset.
Experience with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Engineering and Information Technology
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr