Manager, CAPA Compliance

Getinge•Fraser, MI

7d•$120,000 - $150,000•Hybrid

About The Position

The Manager, CAPA Compliance oversees and guides 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. The role 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 partners with Quality, Regulatory Affairs, Manufacturing, Operations, R&D, Post-Market Surveillance, and Supply Chain to resolve quality issues, drive continuous improvement, and maintain inspection readiness. The position also supports Quality operations elements of the Healthmark Quality Management System and oversees the Quality department under the supervision of the Senior Manager, Quality Systems & Compliance.

Requirements

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 a high level of accuracy.
Demonstrated ability to create and update standard operating procedures (SOPs) and work instructions (WIs).
Knowledge of current applicable Quality and Regulatory standards, guidance documents, and industry working groups.
Ability to communicate orally and in writing with organizational members and external parties regarding Quality issues.
Ability to organize and prioritize daily duties.
Ability to work as a team player with teams representing all areas of the organization.
Problem-solving and decision-making ability, including identifying and solving problems, acting decisively, and exercising good judgment.
Ability to maintain appropriate focus on short-term and long-term goals.
At least 8 years of Quality Assurance, Quality Engineering, Quality Systems, or Regulatory Compliance experience within the medical device industry.
At least 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.

Responsibilities

Perform Quality functions in compliance with the Quality Management System (QMS), 21 CFR 820, 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.
Maintain CAPA metrics, KPI reporting, and process effectiveness indicators.
Drive timely CAPA closure 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.
Provide recommendations and subject matter expertise regarding CAPA-related quality and compliance risks.
Participate in third-party audits, including FDA and Notified Body audits, and help provide responses to observations.
Develop and provide internal training on the CAPA process, procedures, and applicable QMS software.
Assist management with ongoing Quality improvement initiatives and track or trend Quality System metrics.
Determine sources of Quality problems, recommend improvements, and assist with corrective and preventive actions.
Foster a culture of accountability, compliance, and continuous improvement.
Approve timesheets and vacation/paid time off requests for direct reports.
Perform other duties as assigned or needed.