Senior Quality Systems Specialist - FDA Readiness

What You Can Expect

The primary responsibility of this position is to assure conformance to established requirements and standards for products and processes through the effective implementation of the Quality Management System (QMS). This role requires mandatory, hands-on experience hosting FDA and Notified Bodies (NB's) inspections, leading FDA\NB's audit preparation, and owning QMS remediation initiatives. The position entails full accountability for regulatory inspection readiness, direct interaction with FDA\NB's investigators, and execution of sustainable QMS remediation actions. Explicit accountability for QMS remediation aligned to FDA QMSR and 21 CFR Part 820.

How You'll Create Impact

• Develop, implement, and continuously improve QMS processes, procedures, and work instructions.
• Act as primary Quality host for FDA\NB's inspections, serving as the direct interface to FDA investigators.
• Lead all FDA\NB's inspection preparation activities, including inspection readiness assessments, mock audits, document traceability, and site coaching.
• Own and manage QMS remediation projects arising from FDA\ NB's inspections, FDA Form 483 observations, internal audits, and regulatory authority findings.
• Drive FDA\ NB's -related CAPA development, execution, effectiveness verification, and sustainable closure.
• Coordinate and lead cross-functional remediation teams, managing timelines, risks, and executive communication.
• Lead and support internal, supplier, and regulatory audits for ZB Ireland sites.
• Prepare and lead Quality Management Reviews to ensure ongoing QMS effectiveness

What Makes You Stand Out

• Expert-level capability in hosting FDA inspections and managing real-time regulatory interactions.
• Proven ability to independently prepare, present, and defend QMS processes during FDA inspections.
• Demonstrated leadership of FDA audit preparation and inspection readiness programs.
• Strong project management expertise applied to QMS remediation initiatives.
• Proven ownership of FDA-related CAPAs, including root cause analysis, implementation, and effectiveness checks.
• Deep working knowledge of FDA Quality System Regulation (21 CFR Part 820).
• Ability to operate decisively and credibly under regulatory audit pressure.
• Strong written and verbal communication skills
• Deep working knowledge of QMSR + 21 CFR 820
• Ability to defend compliance to FDA investigators

Your Background

• Bachelor's degree in engineering or scientific discipline required, or equivalent degree with Quality certification (e.g. CQE).
• Minimum of 5 years of experience in Quality Engineering, Quality Compliance, or Quality Systems.
• Mandatory demonstrated experience hosting FDA inspections with direct FDA investigator engagement.
• Mandatory experience leading FDA audit preparation and inspection readiness activities.
• Proven leadership of QMS remediation projects resulting from FDA inspections and FDA Form 483 observations.
• Candidates without direct FDA inspection hosting and remediation ownership experience will not be considered
• Demonstrated application of QMSR and Part 820 made mandatory

Travel Expectations

• Up to 20% for internal audit or business meetings as required