Manager, Quality Systems & Compliance CAPA

Getinge•Fraser, MI

7d•$120,000 - $150,000•Hybrid

About The Position

The Quality Systems & Compliance CAPA Manager oversees and guides Quality Technicians, Coordinators, Specialists, and cross-functional teams responsible for investigations, root cause analysis, remediation, effectiveness verification, and regulatory compliance for the CAPA Program. The role provides operational leadership and oversight of 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 teams to resolve quality issues, promote continuous improvement, and support 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. The role leads and maintains the Healthmark CAPA program, ensures compliance with applicable regulatory and internal requirements, reviews investigations, manages CAPA metrics and governance, and leads remediation activities. It also participates in third-party audits, provides CAPA training, supports Quality improvement initiatives, and fosters accountability, compliance, and continuous improvement.

Requirements

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.
Advanced root cause analysis experience.
Strong statistical problem-solving skills and 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, with attention to detail and accuracy.
Demonstrated ability to create and update standard operating procedures and work instructions.
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 about Quality issues.
Ability to organize and prioritize daily duties, work effectively with teams across the organization, solve problems, make decisions, and maintain focus on short- and long-term goals.

Responsibilities

Perform Quality functions in compliance with the QMS, including 21 CFR 820, ISO 9001:2015, and ISO 13485:2016.
Lead and maintain the Healthmark CAPA program and ensure activities comply with FDA QMSR, ISO 13485, internal procedures, and applicable regulatory requirements.
Review and approve investigations for adequacy, completeness, and regulatory compliance.
Maintain CAPA metrics, KPI reporting, and process effectiveness indicators; track and trend Quality System metrics.
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 and 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 and 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 Quality System audits, including FDA and Notified Body audits, and assist with responses to observations.
Develop and deliver internal training on the CAPA process, procedures, and applicable QMS software.
Assist management with ongoing Quality improvement initiatives and 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.