QA Manager

Roles and Responsibilities

• Ensure QMS processes such as Document Control, Complaint Management, Post-Market activities, CAPA, Training, etc meet all applicable quality & regulatory standards.
• Write, update, and review quality documents, procedures, policies and business processes ensuring on-going compliance with current regulations, standards and applicable certifications.
• Aid and lead in investigating nonconformities and use appropriate tools to determine the root cause.
• Develop product knowledge to make informed decisions that influence product quality and safety.
• Support audits by promptly delivering complete and accurate records.
• Work with other stakeholders in the company to track and monitor successes and pain points of QMS processes.
• Implement improvements to drive compliance, quality, and efficiency of these 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 otherwise).

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, either Medical Devices or Pharmaceuticals, preferably with Software as a Medical Device (SaMD).
• Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements, including but not limited to 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 the Medical Device or Pharmaceutical industry, or in Design Engineering or Manufacturing Engineering in the Medical Device field.
• Demonstrated expertise in root cause analysis.
• Strong influencing skills and ability to clearly communicate the requirements to cross-functional teams.
• Exceptional critical thinking, problem-solving, root-cause analysis, and process improvement skills.
• Proficiency in managing multiple priorities effectively.
• Takes initiative, manages time effectively, and is motivated to achieve goals without constant oversight.

Legal Authorization

Legal authorization to work in the U.S. is required.

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 who are 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).

COVID-19 Vaccination Requirement

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance

No