We are seeking a Staff CAPA Specialist with strong CAPA and quality systems expertise who excels in a regulated environment. The ideal candidate is a collaborative problem solver who can influence stakeholders across functions, navigate complex quality challenges, and drive continuous improvement initiatives. This individual thrives in a matrixed organization, demonstrates exceptional attention to detail, and effectively balances compliance requirements with business needs.

What You Will Do

• Review and approve NC and CAPA records for completeness, effectiveness, accuracy, timeliness, and compliance.
• Approve documentation changes, extensions, and corrective action plans.
• Serve as local SME and process owner for NC/CAPA processes and procedures.
• Ensure compliance with corporate and local quality requirements.
• Partner with teams to guide investigations and CAPA activities through all process stages.
• Coach and train teams on CAPA principles, problem solving, and the global eCAPA system.
• Mentor users and quality professionals on CAPA best practices.
• Promote effective root cause analysis, problem solving, and human error reduction methods.
• Improve CAPA processes, quality systems, reporting, and operational effectiveness.
• Identify process improvements aligned with corporate quality strategy.
• Lead and support cross-site, multi-site, and global quality projects.
• Support development of global quality procedures and standards.
• Monitor site CAPA performance and quality metrics.
• Report updates to quality leadership and business review forums.
• Lead CAPA review board meetings and quality governance activities.
• Ensure compliance with global quality metrics and reporting expectations.

• Lead audit preparation, participation, and follow-up for internal, corporate, customer, and third-party audits.
• Represent local CAPA processes during inspections and audits.
• Support regulatory agency and auditor interactions as a quality systems expert.
• Maintain readiness and compliance with applicable regulatory standards.

What You Need

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• Minimum 4 years of experience in CAPA, Quality Systems, Engineering, or a related function within a regulated industry.
• Strong knowledge of Quality Management Systems (QMS) and CAPA processes.
• Experience leading investigations, corrective actions, and continuous improvement initiatives.
• Strong project management, communication, and stakeholder management skills.
• Ability to work independently with minimal supervision while managing multiple priorities.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
• Ability to learn and effectively utilize new software systems.
• Fluent English communication skills (written and verbal).

Preferred

• Master's degree preferred.
• Experience within the medical device, pharmaceutical, or other highly regulated industries.
• Strong knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, MDSAP, and other applicable global regulatory requirements.
• Experience interacting with regulatory agencies and notified bodies such as FDA, BSI, TÜV, or Ministry of Health representatives.
• Knowledge of supporting quality processes including audits, management review, and quality planning.
• Demonstrated success leading projects within a global matrix organization.
• Advanced analytical, critical thinking, and problem-solving capabilities.
• Experience serving as a CAPA Process Owner, Quality Systems Specialist, or eCAPA Super User.
• Previous experience leading cross-functional and global quality initiatives.

United States of America Pay Ranges:

• USN: $83,300 - $138,800 USD Annual

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