QA Manager

HC2022 MIM Software Inc.; Beachwood (OH); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Competitive compensation

Professional development

Job summary

GE HealthCare in Beachwood, Ohio is seeking a QA Manager to lead the quality system, support Document Control, Training and Complaint Management, and ensure compliance with FDA 21 CFR 820, ISO 13485, and MDSAP.

You will guide investigations of nonconformities, mentor a cross-functional team, participate in audits, and drive process improvements to safeguard patient safety and product quality.

Qualifications

• Bachelor's degree required in a related field.
• 7+ years QA experience in a regulated industry (Medical Devices or Pharmaceuticals), SaMD preferred.
• Strong knowledge of FDA 21 CFR 820, ISO 13485, and MDSAP.
• Experience leading a quality team and resolving conflicts.

Responsibilities

• Ensure QMS processes meet applicable quality and regulatory standards.
• Write, update, and review quality documents, procedures, and policies.
• Lead investigations of nonconformities and determine root causes.
• Develop product knowledge to inform decisions on quality and safety.
• Support audits with complete and accurate records in a timely manner.
• Collaborate with stakeholders to monitor QMS performance and improvements.
• Assist in risk assessments and mitigation planning; participate in audits.

Skills

Quality system leadership

Regulatory compliance

Cross-functional collaboration

Root cause analysis

Education

Bachelor's degree

Tools

CAPA management software

Document control systems

Job description

Overview

The QA Manager is a versatile member of the Quality team who will support Document Control, Training, and Complaint Management activities to ensure processes and outputs adhere to applicable FDA, EU regulations, ISO 13485:2016, and other governing regulations relevant to MIM Software. This role maintains the MIM Software Quality System and ensures adherence to the MIM/GE HealthCare Quality Management System and regulatory requirements, including 21 CFR 820, ISO 13485, and MDSAP. The position requires strong critical thinking and cross-functional collaboration to support patient safety, audit readiness, and the delivery of MIM Software/GE HealthCare systems. Legal authorization to work in the U.S. is required.

Responsibilities

• Ensure QMS processes (Document Control, Complaint Management, Post-Market activities, CAPA, Training, etc.) meet applicable quality and regulatory standards.
• Write, update, and review quality documents, procedures, policies, and business processes to maintain ongoing regulatory compliance.
• Assist and lead investigations of nonconformities and determine root causes using appropriate tools.
• Develop product knowledge to inform decisions affecting product quality and safety.
• Support audits by delivering complete and accurate records in a timely manner.
• Collaborate with stakeholders to track and monitor successes and pain points of QMS processes.
• Implement improvements to drive compliance, quality, and efficiency of QMS processes.
• Participate in risk assessments, risk mitigation strategies, and risk management plans; provide review/approval as needed.
• Assist during audits in the room (supplier, critical supplier, notified body, or others).
• Maintain proficiency with MIM’s product portfolios and Primary Products classifications.
• Stay current with guidance documents, regulatory requirements, and industry best practices.
• Assist in other areas of the QMS as directed by the manager.

Required Qualifications

• Bachelor's degree from an accredited university or college.
• At least 7 years of relevant experience in Quality Assurance in a regulated industry (Medical Devices or Pharmaceuticals), preferably with Software as a Medical Device (SaMD).
• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements, including FDA CFR 21 (820), ISO 13485, and MDSAP.
• Demonstrated experience in leading and managing a team effectively.
• Demonstrated ability to collaborate effectively and resolve conflicts.

Desired Characteristics

• Experience in Quality Assurance or Quality Engineering within Medical Devices or Pharmaceuticals, or in Design/Manufacturing Engineering in the Medical Device field.
• Expertise in root cause analysis; strong influencing and cross-functional communication skills.
• Exceptional critical thinking, problem-solving, and process improvement skills.
• Ability to manage multiple priorities and adapt to a dynamic environment; takes initiative and works with limited oversight.
• Proactive in identifying opportunities and solving problems independently.

Additional Information

• GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.
• GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
• GE HealthCare will only employ those legally authorized to work in the United States for this opening.
• Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
• While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers may have vaccination mandates.
• Relocation Assistance Provided: No
• At GE HealthCare, we see possibilities through innovation and partner with our customers to fulfill healthcare’s greatest potential.