Senior QA Manager – Medical Devices & SaMD QMS

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

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.