Senior CAPA & Quality Systems Lead

Stryker; Arlington (TN); On-site; USD 83,300 - 138,800; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Wellbeing program

Job summary

Stryker is seeking a Staff CAPA Specialist to lead CAPA and quality systems within a regulated environment. You will influence stakeholders across functions, drive continuous improvement, and ensure readiness for audits and inspections.

The role requires extensive CAPA experience, QMS knowledge, and the ability to navigate a matrixed organization while balancing compliance with business needs. Strong problem-solving and training capabilities are essential.

Qualifications

• 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.

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.

Skills

CAPA

Quality Systems

Engineering

Regulated industry

Project management

Stakeholder management

Communication

Independent work

MS Office

Fluent English

Education

Bachelor's degree in Engineering/Science

Tools

MS Office

Job description

Stryker is seeking a Staff CAPA Specialist to lead CAPA and quality systems within a regulated environment. You will influence stakeholders across functions, drive continuous improvement, and ensure readiness for audits and inspections.

The role requires extensive CAPA experience, QMS knowledge, and the ability to navigate a matrixed organization while balancing compliance with business needs. Strong problem-solving and training capabilities are essential.