Senior Quality Assurance Specialist

Job Title: Sr. QA SpecialistLocation: South San FranciscoIndustry: Medical DeviceStyle: HybridLength of Contract: Initial 6-12 Months with potential extensionJob SummaryThe Senior Quality Systems Specialist is responsible for managing and supporting the Quality Management System (QMS), including areas such as document control, training, CAPA (Corrective and Preventive Actions), internal and supplier audits, nonconformance management, and assisting with production-related tasks such as incoming inspections, rework, and deviation handling. This role also involves planning and supporting quality-related projects to align with company objectives.Essential ResponsibilitiesCAPA Management: Oversee all CAPA processes from initiation and investigation to implementing corrective actions, verifying effectiveness, and closing CAPAs.Internal Audits: Manage the internal audit schedule, lead or facilitate audits, and ensure findings are addressed and resolved. Support external audits of the company's QMS.Document Control: Assist with document change control, retention, and maintenance of quality records (e.g., CAPA files, nonconformance records, internal audit files, manufacturing records, and Design History Files).Training Administration: Coordinate onboarding training, manage training assignments, log completed training, and maintain accurate training records.Quality Logs: Maintain logs for quality records, including nonconformance, CAPA, and rework logs.Supplier Management: Handle supplier qualification, maintain the Approved Suppliers List (ASL), manage supplier files, and oversee the Supplier Corrective Action Request (SCAR) program.Management Review Support: Assist the Director of QA in preparing materials for management reviews.Employee Guidance: Provide training and support to staff on quality processes and procedures.Production Quality Support: Conduct quality reviews of inspection and manufacturing device/lot history records.Regulatory Compliance: Ensure adherence to client's QMS and applicable regulatory requirements.Health & Safety: Follow company health and safety policies.Other Duties: Perform other tasks as assigned by management.QualificationsExperience:Minimum of 5+ years in quality operations within the medical device industry.Experience managing document control systems and training programs.Experience with electronic Quality Management Systems (eQMS); administration experience is preferred.Knowledge, Skills, and Abilities:Strong knowledge of FDA regulations (21 CFR 820), ISO 13485, and ISO 14971.Proficient in Microsoft Word and Excel.Ability to work independently.Excellent verbal and written communication skills.Strong problem-solving abilities.Excellent interpersonal skills with a collaborative, team-oriented mindset.Education:Bachelor's degree in a technical or scientific field preferred.Physical Demands:Activities may involve sitting, standing, or walking.Must be able to lift and carry up to 50 lbs.

Created: 2025-02-22