GE HealthCare
Overview
This position is in GE Healthcare's MIM Software business, which makes vendor-neutral imaging software to standardize workflows and simplify increasingly complex clinical scenarios. Leading global healthcare organizations use MIM to provide patients with more precise, personalized care. QA Manager is a versatile and dynamic member of the Quality team. They will support the CAPA system, Complaint Management and Document Control activities to ensure that processes and outputs adhere to applicable FDA, EU regulations, ISO 13485:2016, and other governing regulations applicable to MIM Software. They will also stay up to date with industry requirements and develop a deep understanding of company processes to build a robust and efficient QMS to support the business. The QA Manager is responsible for adherence to the MIM Software Quality System. The role supports adherence to the MIM/GE HealthCare Quality Management System and regulatory requirements, including 21 CFR 820, ISO 13485, and MDSAP, influencing cross-functional teams to ensure robust quality decisions. This role directly impacts patient safety, audit readiness, and the commercial delivery of MIM Software/ GE HealthCare systems. Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening. What You'll Do
Ensure QMS processes such as Document Control, Complaint Management, Post-Market activities, CAPA, Training, etc., meet all applicable quality and regulatory standards. Write, update, and review quality documents, procedures, policies and business processes to ensure ongoing compliance with current regulations, standards and applicable certifications. Assist 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 delivering complete and accurate records. Work with other stakeholders in the company to track and monitor success 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). Proficient knowledge of MIM’s product portfolios and Primary Products and classifications. Stay current with the latest guidance documents, regulatory requirements, and industry best practices. Assist in other areas of the QMS as directed by the manager. What You'll Need
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 Part 820, ISO 13485, and MDSAP. Legal authorization to work in the U.S. is required. Sponsorship for employment visas is not available. 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 requirements to cross-functional teams. Exceptional critical thinking, problem-solving, root-cause analysis, and process improvement skills. Proficiency in managing multiple priorities effectively. Thrives in a dynamic environment and is comfortable navigating change. Takes initiative, manages time effectively, and is motivated to achieve goals without constant 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 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). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers may have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No
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This position is in GE Healthcare's MIM Software business, which makes vendor-neutral imaging software to standardize workflows and simplify increasingly complex clinical scenarios. Leading global healthcare organizations use MIM to provide patients with more precise, personalized care. QA Manager is a versatile and dynamic member of the Quality team. They will support the CAPA system, Complaint Management and Document Control activities to ensure that processes and outputs adhere to applicable FDA, EU regulations, ISO 13485:2016, and other governing regulations applicable to MIM Software. They will also stay up to date with industry requirements and develop a deep understanding of company processes to build a robust and efficient QMS to support the business. The QA Manager is responsible for adherence to the MIM Software Quality System. The role supports adherence to the MIM/GE HealthCare Quality Management System and regulatory requirements, including 21 CFR 820, ISO 13485, and MDSAP, influencing cross-functional teams to ensure robust quality decisions. This role directly impacts patient safety, audit readiness, and the commercial delivery of MIM Software/ GE HealthCare systems. Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening. What You'll Do
Ensure QMS processes such as Document Control, Complaint Management, Post-Market activities, CAPA, Training, etc., meet all applicable quality and regulatory standards. Write, update, and review quality documents, procedures, policies and business processes to ensure ongoing compliance with current regulations, standards and applicable certifications. Assist 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 delivering complete and accurate records. Work with other stakeholders in the company to track and monitor success 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). Proficient knowledge of MIM’s product portfolios and Primary Products and classifications. Stay current with the latest guidance documents, regulatory requirements, and industry best practices. Assist in other areas of the QMS as directed by the manager. What You'll Need
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 Part 820, ISO 13485, and MDSAP. Legal authorization to work in the U.S. is required. Sponsorship for employment visas is not available. 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 requirements to cross-functional teams. Exceptional critical thinking, problem-solving, root-cause analysis, and process improvement skills. Proficiency in managing multiple priorities effectively. Thrives in a dynamic environment and is comfortable navigating change. Takes initiative, manages time effectively, and is motivated to achieve goals without constant 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 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). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers may have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No
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