Senior Quality Systems Specialist

WHAT YOU WILL BRING TO THE TEAM

The Sr. Quality Systems Specialist will be responsible for maintaining elements of the Quality Management System (QMS) in compliance with ISO 13485 and elements of 21 CFR 820, tracking QA performance goals. Specifically, this includes Document Control, management of product complaint files, maintenance of Corrective and Preventive Action (CAPA), maintaining supplier files, administration of the company training program and training records, audits, and risk management activities. Opportunities will arise to assist with clinical and regulatory submissions. This position may also assist with customer order processing and inventory management (as needed). Key responsibilities include: Document Control Review and update controlled documentation Facilitate documentation review by required team members Prepare change order (CO) packages for all team members (QA, Marketing, Clinical, etc.) and obtain approval Release new controlled documents into electronic systems Maintain and organize documentation in electronic systems Assist team members in locating documentation in electronic systems CAPA processing Maintain the CAPA log Provide reminders to team members to facilitate on time completion of CAPA milestones Review and assist staff documenting root causes and corrective actions Route CAPA documentation for approval and maintain approval records and other CAPA documentation in electronic systems Track and trend CAPA and Supplier and Corrective Action Reports (SCAR) and report to management monthly and at Management Review Serve as point person for opening new complaints Collect complaint information from internal and external sources Facilitate return (via Returned Goods Authorization (RGA), and decontamination of complaint product Facilitate and maintain return product kits at customer sites Review complaint files for completeness and follow-up with responsible parties (contract manufacturer) for investigation outcomes Route complaint documentation for approval and closure Maintain and organize complaint file documentation Ensure MDR decisions are filed, documented, and stored appropriately and in a timely manner Maintain tracker for complaint metrics and report status monthly and at Management Review Manage the Approved Supplier List (ASL) Facilitate and document approval of new suppliers based on risk determination Communicate and coordinate with suppliers for completion of necessary paperwork (certificates, surveys, audits, resumes, etc.) Route supplier documentation for approval from QA Director Review supplier status as required for any additional actions or updated documentation Maintain and organize supplier documentation Coordinate with team members to ensure accuracy of ASL Training Administer the Company’s electronic learning management system, eLeap, including maintaining training assignments, records, employee profiles, and training requirements Maintain training logs/requirements and continuously track progress for all employees, creating records and helping them complete required training Evaluate the training process for effectiveness and propose and implement improvements Develop and conduct annual QMS group training presentations needed to ensure compliance with regulatory requirements Maintain external training certificates and track expiration dates (i.e. sexual harassment training, HIPAA, GCP, etc.) Obtain and track electronic signature certification for new and existing employees Assist with employee on-boarding and off-boarding activities and route and file approved documentation. Send training reminders to achieve completion on time and report status to management monthly and during management review. Audit Preparation Ensure every aspect of the QMS (training, CAPAs, complaints, NCRs, quality records, etc.) is maintained without any gaps in documentation or errors to meet external and internal audit requirements Issue internal audit schedule and coordinate internal audit schedule Communicate with auditor and supply requested documentation either prior to or at the time of the audit Assist during the audit to answer questions and provide any additional documentation Ensure all audit documentation is completed and filed appropriately Open any needed CAPAs resulting from audit findings Report any audit findings to management monthly and at Management Review Regulatory Files Assist with maintenance of product technical documentation Assist with updates to the QMS Prepare and create presentation for Management Review Assist with filings to regulatory bodies Assist with recalls Assist in the preparation of data or slides for Board of Directors (BoD) meetings Order Processing/Finished Goods Inventory Tracking (if needed) Provide short- or long-term support for order processing and finished goods inventory, including filing customer POs, coordinating Sales Orders, tracking shipments, and maintaining related records Communicate with internal team members, contract manufacturers, and customer sites as needed to support timely product availability and accurate records. Other assignments may be added in the future

REQUIRED EDUCATION

Bachelor’s degree, in life sciences, engineering, or equivalent preferred

DESIRED EXPERIENCE

3+ years of experience working as a Quality Assurance/Quality Systems Specialist American Society of Quality (ASQ) membership a plus Working and applied knowledge of US FDA 21CFR 820 Quality System Regulation, design control and ISO 13485 Quality Management Systems in order to maintain compliance with US regulatory requirements for product realization. Highly proficient with MS Office (Word, Excel, Outlook) Knowledge of VBA a plus Ability to read and redline manufacturing documentation including Work Instructions, Lot History Records, and component specifications. Excellent attention to detail and accuracy Ability to manage and prioritize multiple tasks with minimal direction, working effectively both independently and within a multi-disciplinary team Ability to research and pull scholarly articles

WHAT'S IN IT FOR YOU

RenovoRx offers a competitive compensation and benefits package, including an annual bonus opportunity, stock options, medical/dental/vision, 401(k) (with match program), cell phone stipend, monthly lifestyle benefit reimbursement, and paid holidays, vacation, and sick time. Additionally, you will have the opportunity to: Make an impact: your work will directly impact cancer patient populations where no improvements have been made in their treatment in decades Work with the best: The RenovoRx team is comprised of highly experienced and successful team members devoted to making an impact on cancer as well as helping others grow their careers Become your best: RenovoRx believes in culture and offers frequent team-building events as well as employee growth and promotion opportunities Own it: you will be the CEO of your job and be recognized for your hard work by your colleagues, investors, and most importantly, study sites and patients

AAP/EEO STATEMENT

RenovoRx is an Equal Opportunity Employer and values diversity. We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by applicable laws, regulations, and ordinances.

ADDITIONAL DETAILS

Please note this job description may not encompass all activities, duties, and responsibilities required for this role. Duties, responsibilities, and activities may change at any time, with or without notice. This is an in-house, full-time position based in Mountain View, California, with the potential to work hybrid 1-2 times a week. This role will require the ability to sit for extended periods using a computer or a phone, share a workspace maintained in good order, potentially lift up to 20 lbs., and work alone or with others in a small office environment. #J-18808-Ljbffr RenovoRx (Nasdaq: RNXT)