Quality Systems & CAPA Manager — Hybrid

Getinge; Fraser (MI); Híbrido; USD 120.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Wellness initiative & Health Resources

Life Insurance

Short and Long Term Disability

Health and Dependent Care FSAs

Parental and Caregiver Leave

Tuition Reimbursement

Descripción de la vacante

Getinge in Fraser, MI is seeking a Manager, Quality Systems & Compliance CAPA to lead investigations, root cause analysis and remediation activities across cross-functional teams. You will drive timely CAPA closure, maintain quality metrics, and ensure regulatory compliance under 21 CFR 820 and ISO standards.

This role partners with Quality, Regulatory Affairs, Manufacturing, Operations, R&D, and Supply Chain to strengthen data integrity, readiness for FDA inspections, and continuous

Formación

• 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.

Responsabilidades

• Performs all Quality functions in compliance with 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.
• FDA inspection preparation
• FDA 483 remediation
• Warning Letter remediation
• Consent Decree activities
• Internal audit findings
• External audit observationsManagement 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.
• May be required to perform other duties as assigned or as needed.

Conocimientos

Root Cause Analysis

Statistical analysis

Data-driven decisions

Quality documentation

Regulatory knowledge

Communication

Leadership

Descripción del empleo

Getinge in Fraser, MI is seeking a Manager, Quality Systems & Compliance CAPA to lead investigations, root cause analysis and remediation activities across cross-functional teams. You will drive timely CAPA closure, maintain quality metrics, and ensure regulatory compliance under 21 CFR 820 and ISO standards.

This role partners with Quality, Regulatory Affairs, Manufacturing, Operations, R&D, and Supply Chain to strengthen data integrity, readiness for FDA inspections, and continuous