Careers

Quality Assurance – Sr. Quality Systems Specialist

What You Will Bring to the Team

The QA 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, the QA Sr. Quality Systems Specialist will be responsible for 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
  • Update document control logs
  • 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
• Complaint Handling:
  • 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
• Supplier Qualification:
  • 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 and training requirements for all employees
  • Continuously track training progress for all employees and create training records while working with employees to complete necessary 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)
  • Short-term or long-term support of order processing and finished goods inventory tracking
  • Short-term or long-term assistance with filing customer Purchase Orders, coordinating Sales Orders, tracking shipment status, and maintaining related inventory and shipment documentation
  • 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 21 CFR 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 and remain focused on personal objectives with minimal direction
• Proven ability to work effectively independently and in a multi-disciplinary team
• Ability to research and pull scholarly articles

Desired Skills

• Positive, flexible outlook
• Strong interpersonal communication skills with the ability to effectively communicate across all levels
• Ability to work across multiple online or electronic platforms/software programs
• Adaptability
• Time management
• Organization
• Dependable
• Team player
• Sit for extended periods of time using a computer or phone
• Share a workspace and maintain good order
• Lift up to 20 lbs. infrequently
• Work alone or with others in an office environment
• PC proficiency
• Office equipment (scanner, copier, phones)

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, or 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.