Manager, CAPA Compliance

Job Overview

The Manager, CAPA Compliance oversees and provides guidance to Quality Technicians, Coordinators, Specialists and Cross Functional teams responsible for investigations, root cause analysis, remediation activities, effectiveness verification, and regulatory compliance for the CAPA Program. This position provides operational leadership and oversight for the CAPA process, ensuring timely investigation, resolution, and effectiveness of corrective and preventive actions in support of organizational quality and compliance objectives.

The Manager, CAPA Compliance serves as a key partner to Quality, Regulatory Affairs, Manufacturing, Operations, R&D, Post-Market Surveillance, and Supply Chain teams to drive timely resolution of quality issues, continuous improvement, and inspection readiness. This position will also support Quality operations elements of the Healthmark Quality Management System (QMS) and oversees the Quality department under the supervision of Senior Manager, Quality Systems & Compliance.

Job Responsibilities and Essential Duties

• Performs all Quality functions in compliance with Quality Management System (QMS) according to 21CFR820 and ISO 9001:2015 and ISO 13485:2016.
• Lead and maintain the Healthmark CAPA program.
• Ensure CAPA activities comply with FDA QMSR, ISO 13485, internal quality procedures, and applicable regulatory requirements.
• Review and approve investigations for adequacy, completeness, and regulatory compliance.
• Maintains CAPA metrics, KPI reporting, and process effectiveness indicators.
• Drive timely closure of CAPAs while ensuring quality and regulatory compliance.
• Oversee CAPA governance, prioritization, escalation, and management review reporting.
• Identify systemic quality issues and opportunities for continuous improvement.
• Lead CAPA remediation programs supporting FDA inspection preparation, FDA 483 remediation, Warning Letter remediation, Consent Decree activities, internal audit findings, external audit observations, and Management Review actions.
• Assess historical CAPA records for compliance gaps and remediation opportunities.
• Strengthen investigation quality, data integrity, and documentation practices.
• Facilitate issue resolution across multiple functional areas.
• Lead CAPA review boards and quality review meetings.
• Provides recommendations and subject matter expertise regarding CAPA-related quality and compliance risks.
• Participates in third party audits (FDA, Notified Body) of the Quality System and assists with providing responses to any observations made during those audits.
• Develops and provides internal training on CAPA Process and Procedures and the applicable QMS software.
• Assists management with ongoing Quality improvement initiatives.
• Tracks or trends Quality System Metrics.
• Determines source of Quality problems, makes recommendations for improvement, and assists with corrective and preventative actions.
• Foster a culture of accountability, compliance, and continuous improvement.
• Approves timesheets for vacation/paid time off requests for Direct reports.

Required Knowledge, Skills and Abilities

• Advanced Root Cause Analysis experience.
• Strong statistical problem-solving skills.
• Experience with data-driven decision making.
• Ability to evaluate large volumes of quality records and identify systemic issues.
• Strong technical writing and documentation review skills.
• Attention to detail and high level of accuracy.
• Demonstrated ability to create and update standard operating procedures (SOP) and work instructions (WI).
• Knowledge of current applicable Quality and Regulatory standards, guidance documents and industry working groups.
• Communicating both orally and written with members of the organization, as well as external parties relating to Quality issues.
• Organizing and prioritizing daily duties.
• Must be a team player and able to work well with teams representing all areas of the organization.
• Problem solving and decision making – identifies and solves problems, acts decisively, and shows good judgement.
• Maintaining appropriate focus on short-term and long-term goals.

Minimum Requirements

• 8+ years of Quality Assurance, Quality Engineering, Quality Systems, or Regulatory Compliance experience within the Medical Device industry.
• 3+ years of leadership experience with direct reports.
• Demonstrated ownership of CAPA systems and quality improvement initiatives.
• Experience managing complex investigations and quality remediation programs.
• Experience supporting FDA inspections and regulatory audits.
• Experience managing cross-functional teams and driving organizational change.