The Senior Quality Analyst supports quality operations by assisting in NCR investigations and ensuring compliance with quality and regulatory requirements. Acting as a backup to the Quality Operations Manager, this role analyzes quality data, reviews inspection records, drives process improvements, and supports audit readiness and QMS enhancements.

REQUIRED EDUCATION, KNOWLEDGE, AND SKILLS

• Bachelor’s degree or equivalent experience
• Minimum of 6 years’ experience in a medical device company
• Understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, ISO 14971, and EU MDR preferred.
• Proficiency with PC-based office computers, including familiarity with Microsoft Office required. Proficiency with statistical software, such as MiniTab, preferred.
• Self-driven with the drive to complete tasks on time.
• Organized, task oriented with focus on the outcome.
• Ability to work as a team member and ability to be very flexible, adaptable and the ability to work under pressure.
• 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 be able to 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.

PHYSICAL REQUIREMENTS:

• 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.
  Disclaimer: EBR Systems Inc. will never ask for personal identifying information (such as Social Security Number, bank account details, or credit card information) during the application process. All communication from EBR Systems Inc. regarding job opportunities will be conducted through official company channels.

ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING:

• Nonconformance Report (NCR) Support: Assist Quality Operations Manager with NCR investigations, including root cause analysis, corrective and preventive actions, and disposition decisions. Ensure timely closure of NCRs and maintain compliance with internal procedures and regulatory requirements. Work closely with Supplier Quality, Operations, Engineering, and Regulatory teams to drive resolution.
• Inspection Prioritization and Support: Serve as the primary point of contact for inspectors in the absence of the Quality Operations Manager. Provide guidance on inspection priorities based on production schedules to ensure timely support for manufacturing operations.
• Quality Metrics and Reporting: Prepare, analyze, and develop manufacturing related Key Process Indicator (KPI) reports for Quality Council and Management Review meetings. Ensure KPIs accurately reflect trends, risks, and opportunities for improvement in manufacturing.
• Inspection and Lot History Record Review: Act as the primary reviewer of inspection records and lot history records. Ensure completeness, accuracy, and compliance with Good Documentation Practices (GDP). Identify and resolve discrepancies before final record approval and retention.
• Process Monitoring and Data Trending: Analyze and interpret process monitoring data, including environmental monitoring, bioburden, and LAL results. Identify trends and escalate potential risks that could impact product quality or compliance. Recommend and implement improvements based on data insights.
• Electronic Quality System Implementation: Lead the transition of paper-based inspection records to electronic systems within MasterControl Mx. Work closely with Operations and Quality Inspectors to develop workflows, train users, and validate system changes to ensure a seamless transition.
• Inspection Process Optimization: Assist in inspection process enhancements by conducting time studies, analyzing defect trends, and implementing process improvements to reduce defects, improve yields, and lower inspection cycle times. Collaborate with Quality Inspectors, Operations, and Engineering teams to drive documentation updates as needed.
• Quality Management System (QMS) Improvements: Draft, edit, and revise quality procedures, work instructions, and forms to support continuous improvement initiatives.

OTHER DUTIES AND RESPONSIBILITIES

• Document Change Order (DCO) Support: Assist in the routing, review, and approval of document changes within MasterControl. Ensure documents are properly authored, formatted, and meet internal procedure requirements before approval.
• 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.