Manager, Quality Systems & Compliance CAPA

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

Benefits offered by this job

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

Job summary

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

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 and identify systemic issues.
• Strong technical writing and documentation review skills.

Responsibilities

• 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.

Skills

Root Cause Analysis

Statistical analysis

Data-driven decisions

Quality documentation

Regulatory knowledge

Communication

Leadership

Job description

Manager, Quality Systems & Compliance CAPA

Date: Oct 23, 2026

Location: Fraser, MI, US

Remote Work: 1-2 days at home (site based)

Salary Range: $120,000-$150,000 per year depending on experience

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

The Quality Systems & Compliance CAPA Manager 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 CAPA Manager 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.
• 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.

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
• 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.

Environmental/Safety/Physical Work Conditions:

• Standing and or sitting for long periods of time.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The salary range for this position is between $120,000-$150,000 per year depending on experience, + 15% STIP

#LI-LG1 LI-Hybrid

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge:

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.