Sr. Quality Specialist - Military veterans preferred

The Position:

As a Senior QA Specialist you will be part of the IVD Quality team that is responsible of the development and implementation of a right sized Quality Management System that includes quality processes and procedures, automated systems, and ensuring compliance with all applicable internal, domestic, and international quality regulations, including ISO 13485, IVDR, and others global regulations and standards.  This is a hybrid role (remote and in office at least 3 days a week) and is based out of our headquarters in South San Francisco (SSF), California, United States.  

Responsibilities

• Support the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and applicable standards and regulations for in vitro diagnostic (IVD) products
• Drive implementation projects for critical QMS elements (eQMS rollout, CAPA process, supplier qualification program, design control workflows)
• Develop and update QMS processes and documentation: SOPs, work instructions, templates (DMR/DHF, CAPA, change control, complaint handling, supplier quality, document control, risk management etc.) in accordance with ISO 13485 and IVDR requirements
• Serve as a Sr. QA subject-matter-expert supporting product development, transfer to CMO, and post market activities for IVDs
• Support design control and technical documentation: review design inputs/outputs, verification and validation protocols and reports, design history files (DHFs), and IVDR technical documentation
• Support process and equipment qualifications (IQ/OQ/PQ) and software validation activities as required
• Manage supplier qualification and ongoing supplier quality monitoring; perform supplier audits and oversee supplier corrective actions
• Implement and maintain risk management per ISO 14971: facilitate risk assessments, ensure residual risk acceptance, and link risk to design changes and CAPAs
• Participate in internal audits and support external audits (notified body, regulatory inspections), prepare audit responses, and lead remediation activities
• Develop, track, and report QMS metrics and KPIs for management review
• Lead and coordinate CAPA investigations and corrective/preventive actions ensure root-cause analysis, implementation, and verification of effectiveness within timelines
• Manage nonconforming product (NCRs), deviations, change control, and product dispositions, ensuring appropriate investigation and documentation
• Oversee complaint handling: lead investigations, support trend analysis and PMS
• Other duties as assigned

Who You Are:

Qualifications

• Bachelors degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field
• 5+ years handson quality assurance experience in the medical device or invitro diagnostic (IVD) industry
• Indepth knowledge of invitro diagnostic device quality requirements, including ISO 13485:2016, IVDR (EU 2017/746) and, ISO 14971:2019 risk management
• Experience implementing and operating a QMS to ISO 13485:2016
• Experience with design control, risk management (ISO 14971), verification & validation, CAPA, change control, complaint handling, and supplier quality
• Experience conducting internal audits and supporting external ISO audits or third-party assessments
• Strong written and verbal communication skills; demonstrated ability to author clear SOPs, technical documents, and audit responses
• Strong organization skills to manage multiple simultaneous projects in a fast-paced environment
• Attention to detail in understanding and documenting complex quality issues
• Strong writing skills to summarize complex issues clearly and accurately
• Strong communication, problem-solving, and motivational skills
• Highly organized, self-motivated, and comfortable working in a fast-paced IVD environment
• ISO 13485 Lead Auditor or equivalent lead auditor certificate is preferred

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