Rani Therapeutics Inc.
The Sr. Quality Engineer supports the Design and Development group and Operations to ensure combination products, components, and materials in development comply with Rani SOPs and applicable regulatory requirements. The ideal candidate will have working knowledge in design control requirements for medical devices and hands‑on experience in the product life cycle from feasibility prototype through product commercialization. The Sr. QE will provide quality and compliance input to the project team for decisions and deliverables (product specifications, test methods, design reviews, design verification & validation, usability testing, software validation, process validation). The candidate should prioritize project activities and work within a multidisciplinary team.
Major Duties and Responsibilities
Support the Product Lifecycle, Design Control, and Design Transfer processes, and the quality elements of design projects.
Provide quality assurance oversight and ensure compliance in combination device development life cycles.
Ensure product development projects and changes to existing products are conducted in compliance with the Quality System Regulations.
Lead risk management activities and participate in cross‑functional teams to develop and maintain Product Risk Management Files (Risk Management Plan & Report, HA, UFMEA, DFMEA, PFMEA, etc.).
Lead test method validation activities and Gage R&R studies for combination products.
Oversee calibration and preventive maintenance program.
Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts, including establishing, reviewing, and approving design inputs/outputs, design verification & validation, process characterization & validation, component qualification.
Identify quality characteristics and validation criteria for components, sub‑assemblies, and finished products.
Work with R&D in the creation of requirements for new products and engineering specifications.
Ensure design projects meet quality goals and regulatory requirements including FDA Quality System Regulations, ISO 13485, EU MDR, and ISO 14971 risk management.
Provide direction to Engineering to establish, implement, and maintain policies and procedures for Design Controls.
Serve as a technical resource for assessing validation requirements, solving test‑related problems, and developing preventive strategies.
Assist in the development and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports.
Support quality assurance activities, including internal and external audits, NCMRs, and CAPAs.
Assist in the development, review, and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
Other duties/activities may be necessary to support departmental or company goals.
Education and/or Job Experience
Minimum eight (8) years of quality assurance/engineering experience in a regulated industry (medical device).
Bachelor of Science degree in Mechanical Engineering or related field.
Demonstrated competency with Medical Devices Design Controls, 21 CFR 820, MDR, ISO 13485.
Experience with Risk Management process (Risk Management Plan/Report, FMEA’s) and ISO 14971:2019.
Understanding of multiple technological areas (software, mechanical, electrical, biomedical, test automation, etc.).
Self‑starter capable of working independently and within a team.
Experience performing statistical analysis (Six Sigma preferred).
CQE and CQA credentials preferred.
Skills and Specifications
Ability to motivate and influence people.
Ability to handle multiple tasks with high attention to detail and strong organizational, planning, and problem‑solving skills.
Good interpersonal and communication skills.
Ability to work as part of a team.
Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports.
Ability to create and provide training.
Good statistical and numerical ability.
Exceptional problem‑solving skills.
Understanding and ability to explain complex quality details to non‑experts.
General Information Position Title: Senior Quality Engineer Department: Quality Reports to: Sr. VP of Quality Purpose of the job: The Sr. Quality Engineer supports the Design and Development group and Operations to ensure combination products, components, and materials in development comply with Rani SOPs and applicable regulatory requirements. The ideal candidate will have working knowledge in design control requirements for medical device and hands‑on experience in product life cycle from feasibility prototype through product commercialization. The Sr. QE will provide quality and compliance input to the project team for project decisions and deliverables (Product Specifications, Test Methods, Design Reviews, Design Verification & Validation, Usability Testing, Software Validation, Process Validation). The candidate shall have the capacity to prioritize project activities and work within a multidisciplinary team.
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Major Duties and Responsibilities
Support the Product Lifecycle, Design Control, and Design Transfer processes, and the quality elements of design projects.
Provide quality assurance oversight and ensure compliance in combination device development life cycles.
Ensure product development projects and changes to existing products are conducted in compliance with the Quality System Regulations.
Lead risk management activities and participate in cross‑functional teams to develop and maintain Product Risk Management Files (Risk Management Plan & Report, HA, UFMEA, DFMEA, PFMEA, etc.).
Lead test method validation activities and Gage R&R studies for combination products.
Oversee calibration and preventive maintenance program.
Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts, including establishing, reviewing, and approving design inputs/outputs, design verification & validation, process characterization & validation, component qualification.
Identify quality characteristics and validation criteria for components, sub‑assemblies, and finished products.
Work with R&D in the creation of requirements for new products and engineering specifications.
Ensure design projects meet quality goals and regulatory requirements including FDA Quality System Regulations, ISO 13485, EU MDR, and ISO 14971 risk management.
Provide direction to Engineering to establish, implement, and maintain policies and procedures for Design Controls.
Serve as a technical resource for assessing validation requirements, solving test‑related problems, and developing preventive strategies.
Assist in the development and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports.
Support quality assurance activities, including internal and external audits, NCMRs, and CAPAs.
Assist in the development, review, and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
Other duties/activities may be necessary to support departmental or company goals.
Education and/or Job Experience
Minimum eight (8) years of quality assurance/engineering experience in a regulated industry (medical device).
Bachelor of Science degree in Mechanical Engineering or related field.
Demonstrated competency with Medical Devices Design Controls, 21 CFR 820, MDR, ISO 13485.
Experience with Risk Management process (Risk Management Plan/Report, FMEA’s) and ISO 14971:2019.
Understanding of multiple technological areas (software, mechanical, electrical, biomedical, test automation, etc.).
Self‑starter capable of working independently and within a team.
Experience performing statistical analysis (Six Sigma preferred).
CQE and CQA credentials preferred.
Skills and Specifications
Ability to motivate and influence people.
Ability to handle multiple tasks with high attention to detail and strong organizational, planning, and problem‑solving skills.
Good interpersonal and communication skills.
Ability to work as part of a team.
Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports.
Ability to create and provide training.
Good statistical and numerical ability.
Exceptional problem‑solving skills.
Understanding and ability to explain complex quality details to non‑experts.
General Information Position Title: Senior Quality Engineer Department: Quality Reports to: Sr. VP of Quality Purpose of the job: The Sr. Quality Engineer supports the Design and Development group and Operations to ensure combination products, components, and materials in development comply with Rani SOPs and applicable regulatory requirements. The ideal candidate will have working knowledge in design control requirements for medical device and hands‑on experience in product life cycle from feasibility prototype through product commercialization. The Sr. QE will provide quality and compliance input to the project team for project decisions and deliverables (Product Specifications, Test Methods, Design Reviews, Design Verification & Validation, Usability Testing, Software Validation, Process Validation). The candidate shall have the capacity to prioritize project activities and work within a multidisciplinary team.
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