Staff CAPA Specialist

Stryker•Arlington, TN

4d•Hybrid

About The Position

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.

Requirements

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).

Nice To Haves

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.

Responsibilities

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.