QA Manager

GE HEALTHCARE•Beachwood, OH

About The Position

The QA Manager is a versatile and dynamic member of the Quality team. The QA Manager will support the Document Control, Training and Complaint Management 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 keep up to date with the requirements of the industry 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. As a critical member of the team, you will ensure adherence to the MIM/GE HealthCare Quality Management System and regulatory requirements, including 21 CFR 820, ISO 13485, and MDSAP. By employing strong critical thinking and influencing skills, you will work cross-functionally to ensure robust quality decisions. In this role, you will have a direct impact on ensuring 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.

Requirements

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.

Nice To Haves

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.
Thrives in a dynamic environment and is comfortable navigating change
Takes initiative, manages time effectively, and is motivated to achieve goals without constant oversight. You're proactive in identifying opportunities and solving problems independently.

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.
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 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).
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.