Senior CAPA Specialist

Stryker; Mahwah (NJ); On-site; USD 87,000 - 145,000; Full time

Job summary

Stryker is hiring a Senior CAPA Specialist for the Global Quality Operations team supporting the Joint Replacement portfolio in Mahwah, NJ. Working within the QMS to ensure CAPA compliance and reviewing NCs and CAPAs for completeness, accuracy, effectiveness and timeliness.

This role applies CAPA, root cause analysis, and problem-solving methodologies to drive corrective actions, maintain CAPA documentation in TrackWise, facilitate CAPA review meetings, monitor metrics, and support audits and

Qualifications

• Demonstrated experience managing Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes, including root cause investigations, implementation of corrective actions, effectiveness verification, and continuous quality improvement initiatives.

Responsibilities

• Facilitate NC & CAPA teams in problem-solving techniques.
• Partner with cross-functional teams to drive investigations and resolutions.
• Maintain CAPA documentation and records in QMS (e.g., TrackWise).
• Facilitate CAPA review meetings and contribute to quality discussions.
• Monitor CAPA metrics and support quality reviews and audits.

Skills

CAPA management

Root cause analysis

Problem solving

Education

Bachelor’s degree or higher in science/engineering

Job description

Stryker is hiring a Senior CAPA Specialist for the Global Quality Operations team supporting the Joint Replacement product portfolio in Mahwah, NJ. Working within the QMS team to ensure compliance with CAPA processes and procedures and is responsible to but not limited to. Have responsibility for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity and timeliness. Review & Approval of CAPA changes including execution requests.

What You Will Do

• As Problem Solving Methodology expert, facilitate and coach NC & CAPA teams in the application of problem-solving techniques and promote its use and development e.g. Human Error Reduction, 4-D etc.
• Support Nonconformance (NC) and Corrective and Preventive Action (CAPA) activities by partnering with cross-functional teams to drive timely investigations and resolution of quality issues.
• Apply CAPA, root cause analysis, and problem-solving methodologies to support effective corrective and preventive actions.
• Maintain accurate and complete CAPA documentation within electronic quality management systems (e.g., TrackWise), ensuring required evidence and records are documented.
• Assist in facilitating CAPA review meetings and contribute to site, cross-functional, and global quality discussions.
• Monitor CAPA metrics and trends, prepare reports and provide data to support quality and business reviews.
• Provide guidance and support to CAPA process stakeholders, promoting consistent application of quality system requirements and procedures.
• Participate in training, process improvement, and continuous improvement initiatives to enhance CAPA effectiveness and compliance.
• Support internal, corporate, and external audits and contribute to quality system improvement projects and corrective action follow-up activities.

What You Need

Required Qualifications

• Bachelor’s degree or higher in science, Engineering or applicable technical field.
• Minimum 2+ years’ experience working in a medical device or pharmaceutical regulated environment.
• Demonstrated experience managing Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes, including root cause investigations, implementation of corrective actions, effectiveness verification, and continuous quality improvement initiatives.

Preferred Qualifications

• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).
• Knowledge of U.S. FDA and international medical device regulatory requirements and quality system standards.
• Experience in supporting Quality Systems (e.g. Audits, Management review, Quality Planning).

$87,000 - $145,100 USD Annual

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.