Senior Quality Specialist

EBR Systems, Inc. • Sunnyvale, CA

4d

About The Position

The Senior Quality Specialist supports quality systems leading Corrective and Prevention Action (“CAPA”) co-ordination and execution, conducting internal audits under the direction of the Quality Systems Manager, and assembly of management review metrics. Acting as a backup to the Quality Systems Manager, this role executes quality system changes and supports external audit preparations.

Requirements

• Bachelor’s degree or equivalent experience.
• Minimum of 6 years' experience in a medical device company.
• Experience in CAPA and root cause investigation methodologies.
• Certified ISO 13485 Lead Auditor or equivalent medical device auditing experience.
• Understanding of regulatory requirements for the medical device industry, specifically (required) 21 CFR 820, ISO 13845, and (preferred) ISO 14971, MDSAP, TGA, and EU MDR.
• Proficiency with PC-based office computers, including proficiency with Microsoft Office (Word, Excel, PowerPoint) required. Proficiency with MasterControl preferred.
• Self-driven to complete tasks on time.
• Organized, task oriented with focus on the outcome.
• Ability to work as a team member and work under pressure to meet cross-functional timelines.
• Ability to work independently, using good judgement, initiative, and analytical abilities, to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction.
• Ability to be flexible and quickly change direction/responsibility based on existing business needs
• Strong analytical and problem-solving skills, with the ability to make data-driven decisions.
• Effective communication skills for cross-functional collaboration and reporting.
• Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms. Required to stoop, kneel, bend, crouch and lift up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus.
• Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels.

Nice To Haves

• Understanding of regulatory requirements for the medical device industry, specifically (required) 21 CFR 820, ISO 13845, and (preferred) ISO 14971, MDSAP, TGA, and EU MDR.
• Proficiency with PC-based office computers, including proficiency with Microsoft Office (Word, Excel, PowerPoint) required. Proficiency with MasterControl preferred.

Responsibilities

• CAPA Support: Plan and perform CAPA investigations, including root cause analysis, corrective and preventive actions, and disposition decisions. Ensure timely closure of CAPAs and maintain compliance with internal procedures and regulatory requirements. Work closely with Supplier Quality, Operations, Engineering, and Regulatory teams to drive resolution.
• Internal Audits: Act as Lead Internal Auditor for ISO 13485: 2016, TGA and FDA regulation audits. Assist other internal auditors with audit processing, tracking, and CAPA (QRE) assignments.
• Quality Metrics and Reporting: Prepare, analyze, and develop quality related Key Process Indicator (KPI) reports for Management Review meetings. Ensure KPIs accurately reflect trends, risks, and opportunities for improvement in the quality system.
• Quality System Changes: Draft, edit, and revise quality procedures, work instructions, and forms to support continuous improvement initiatives.
• Audit Readiness and Compliance: Support internal and external audit activities by preparing documentation, conducting internal reviews, and ensuring compliance with FDA, ISO 13485, and other regulatory requirements.
• Other duties as assigned: Contribute to special projects and initiatives as required to support the evolving needs of the Quality department.

Benefits

• Medical, dental, and vision insurance provided at no cost for employee-only coverage
• 401(k) matching plan
• Paid Time Off – starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• Life & AD&D and long term disability insurance
• Education assistance
• Voluntary commuter benefits and pet insurance
• Weekly company lunches and occasional happy hour events
• Meaningful work and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 11-50 employees