Senior Quality Engineer

San Jose, CA /
Quality – QA Team /
Full Time
/ On-site
The Sr. Quality Assurance Engineer supports the Design and Development group to ensure devices, components, and materials in development comply with Rani SOP's and applicable regulatory requirements. The ideal candidate will have working knowledge in the 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 (e.g., Product Specifications, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation). The candidate shall have the capacity to prioritize project activities and work within a multidisciplinary team.


    • This individual will be responsible for supporting the Product Lifecycle, Design Control, and Design Transfer processes, as well as the quality elements of design projects
    • Provide Quality Assurance oversight and ensure compliance in the support of 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 on 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 Product
    • 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, subassemblies, and finished product
    • Work with R&D in the creation of requirements for new products and engineering specifications
    • Responsible for assuring design projects meet quality goals, and regulatory requirements including FDA Quality System Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971
    • Provides direction to Engineering to establish, implement, and maintain policies and procedures designed to ensure compliance with all necessary and appropriate quality standards within the area of 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, but not limited to: internal and external audits, NCMRs and CAPAs,
    • Assist in 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

    • A minimum of 8 years quality assurance/engineering in a regulated industry (medical device,) is required
    • BS degree in Mechanical Engineering or related field is required
    • 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 associated standards (ISO 14971:2019)
    • Understanding of multiple technology areas (software, mechanical, electrical, biomedical, test automation, etc.)
    • Must be a self-starter and capable of working independently and within a team.
    • Experience performing statistical analysis (Six Sigma preferred)
    • CQE, CQA preferred

Skills and Specifications

    • Ability to motivate and influence people
    • Must possess the ability to handle multiple tasks with high attention to detail Organizing, planning, and problem-solving skills
    • Good interpersonal and communication skills
    • Ability to work as a 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
    • Understands and can subsequently explain complex quality details to non-experts
Salary Range: $147,000 - $179,985

Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.

Our organization's commitment to Diversity, Equity, and Inclusion is key to making us a better team - one that makes better decisions, drives innovation, and delivers better business results. At Rani Therapeutics, we're committed to a workplace culture where everyone feels comfortable to bring their authentic selves. We pledge to foster inclusion in our organization by promoting psychological safety, embracing differences, and being accountable for our actions. We strive to make Rani a place where each individual feels seen and empowered to reach their highest potential.

Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.