Roles and Responsibilities
- Support and lead QMS activities related to Document Control, QMS management, CAPA, Risk Management andComplaints.
- Lead and Implement improvements to drive compliance, quality, and efficiency of these processes.
- Investigate 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.
- Determine compliance of processes and regulations. Supports efforts to ensure the organization operates within established policies/procedures and complies with all applicable governmental regulations, both domestic and foreign.
- Assist during audits in the room (supplier, critical supplier, notified body, or otherwise)
- Proficient knowledge of MIM’s product portfolios and Primary Products andclassifications.
- 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 (or a high school diploma / GED with at least 4 years of relevant work experience).
- At least 4 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.
- Legal authorization to work in the U.S. is required. Sponsorship for employment visas, now or in the future, for this job opening is not available.
Desired Characteristics
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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.
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Demonstrated expertise in root cause analysis.
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Strong influencing skills and ability to clearly communicate the requirements to cross-functional teams.
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Demonstrated ability to collaborate effectively and resolve conflicts.
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Exceptional critical thinking, problem-solving, root-cause analysis, and process improvement skills.
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Proficiency in managing multiple priorities effectively.
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Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an .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.
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