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.Job Description
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.
- 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.
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.
- 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.
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 have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Skills Required
- Bachelor's degree from an accredited university or college
- At least 7 years of relevant Quality Assurance experience in a regulated medical device or pharmaceutical industry
- Experience with Software as a Medical Device (SaMD), preferably
- Understanding of medical device Quality Management System and regulatory requirements, including FDA 21 CFR 820, ISO 13485, and MDSAP
- Experience leading and managing a team effectively
- Ability to collaborate effectively and resolve conflicts
- Experience in Quality Assurance or Quality Engineering within medical device or pharmaceutical industries, or Design Engineering or Manufacturing Engineering in medical devices
- Expertise in root-cause analysis
- Strong influencing skills and ability to communicate requirements to cross-functional teams
- Critical thinking, problem-solving, root-cause analysis, and process improvement skills
- Ability to manage multiple priorities effectively
- Legal authorization to work in the United States without employment visa sponsorship
GE Healthcare Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GE Healthcare and has not been reviewed or approved by GE Healthcare.
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Healthcare Strength — Healthcare coverage is portrayed as comprehensive, including medical, dental, and vision options with HSA-eligible choices and preventive care coverage. Mental health and well-being support programs are also emphasized as part of the overall package.
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Retirement Support — Retirement support is described as meaningful, with a 401(k) match and additional programs such as student-loan matching in some descriptions. Legacy pension and retiree medical obligations for certain closed groups also signal continued support for long-tenured populations.
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Strong & Reliable Incentives — Variable and role-linked earning opportunities appear attractive in some job families, including high on-target earnings potential in certain sales roles. Additional role-based perks like company cars and travel-related reimbursements further increase the perceived value of total rewards in those positions.
GE Healthcare Insights
What We Do
Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. We embrace a culture of respect, transparency, integrity and diversity.
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