Senior CAPA Specialist

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

Job summary

Stryker is seeking a Senior CAPA Specialist for the Global Quality Operations team in Mahwah, NJ. You will drive CAPA and nonconformance processes, review NCs and CAPAs for accuracy and timeliness, and ensure execution of CAPA changes within the QMS framework.

You will facilitate problem-solving, perform root-cause analysis, and maintain CAPA documentation in TrackWise, supporting audits and cross-functional quality discussions across global sites.

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.

Responsibilities

• Facilitate NC & CAPA teams in applying problem-solving techniques (e.g., 4-D, Human Error Reduction).
• Support NC and CAPA activities by partnering with cross-functional teams to drive investigations and resolution of quality issues.
• Apply CAPA, root cause analysis, and problem-solving methodologies to support effective corrective actions.
• Maintain CAPA documentation in electronic QMS systems (e.g., TrackWise) with complete evidence and records.
• Assist in CAPA review meetings and contribute to quality discussions at site, cross-functional, and global levels.
• Monitor CAPA metrics and trends; prepare reports for quality reviews.
• Provide guidance to CAPA stakeholders to ensure consistent application of quality system requirements.
• Participate in training and continuous improvement initiatives to enhance CAPA effectiveness.
• Support audits and quality system improvement projects and corrective action follow-up.

Skills

CAPA

NC investigations

Root cause analysis

Problem solving

Education

Bachelor's degree in science/engineering

Tools

TrackWise

Job description

Stryker is hiring a Senior CAPA Specialist for the Global Quality Operations team supportingthe 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