CAPA Compliance Manager: Lead QA & Regulatory Excellence

Getinge; Fraser (MI); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Health, Dental, Vision insurance

401k with company match

Paid Time Off

Tuition Reimbursement

Life Insurance

Disability Benefits

Job summary

Getinge in Fraser, MI is seeking a Manager, CAPA Compliance to lead CAPA investigations, root cause analyses, and remediation activities in support of quality and regulatory compliance. This role partners with Quality, Regulatory Affairs, Manufacturing, and R&D to ensure timely resolution of issues and inspection readiness.

The position requires extensive experience in CAPA, FDA inspections, and cross-functional leadership, with a strong emphasis on data integrity, SOP/WI development, and

Qualifications

• Advanced Root Cause Analysis experience.
• Strong statistical problem-solving skills.
• Experience with data-driven decision making.
• Ability to evaluate large volumes of quality records.
• Strong technical writing and documentation review skills.
• 8+ years of Quality Assurance/Quality Systems/Regulatory Compliance in Medical Devices.
• 3+ years of leadership with direct reports.
• Experience supporting FDA inspections and regulatory audits.

Responsibilities

• Lead and maintain the CAPA program and oversee activities.
• Review investigations for adequacy and regulatory compliance.
• Maintain CAPA metrics and reporting.
• Drive timely closure of CAPAs with quality and regulatory compliance.
• Oversee CAPA governance and management review reporting.
• Identify systemic quality issues and drive improvements.
• Assist with FDA inspections and Notified Body audits.
• Develop internal training on CAPA processes.

Skills

Root Cause Analysis

Statistical methods

Data-driven decisions

Documentation review

SOP/WI development

Quality standards knowledge

Communication skills

Time management

Team leadership

CAPA systems

Investigations

FDA inspections

Cross-functional teamwork

Tools

QMS software

Job description

Getinge in Fraser, MI is seeking a Manager, CAPA Compliance to lead CAPA investigations, root cause analyses, and remediation activities in support of quality and regulatory compliance. This role partners with Quality, Regulatory Affairs, Manufacturing, and R&D to ensure timely resolution of issues and inspection readiness.

The position requires extensive experience in CAPA, FDA inspections, and cross-functional leadership, with a strong emphasis on data integrity, SOP/WI development, and