Sr. Quality Engineer

Senior Quality Engineer – Rani Therapeutics Base pay range: $150,000.00/yr - $190,000.00/yr 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 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. 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 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 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 Product. 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 product. Work with R&D in the creation of requirements for new products and engineering specifications. Assure design projects meet quality goals and regulatory requirements including FDA Quality System Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971. Provide 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 as necessary to support departmental or company goals. Education and/or Job Experience Minimum of 8 years quality assurance/engineering in a regulated industry (medical device). BS 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 associated standards (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, CQA preferred. Skills And Specifications Ability to motivate and influence people. High attention to detail and ability to handle multiple tasks. Organizing, planning, and problem‑solving skills. Good interpersonal and communication skills. Teamwork skills. 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. Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Quality Assurance Industry Biotechnology Referrals increase your chances of interviewing at Rani Therapeutics by 2x. Get notified about new Senior Quality Engineer jobs in Fremont, CA. #J-18808-Ljbffr