QA Specialist

GE HealthCare

1d

About The Position

This position is in GE Healthcare's MIM Software business which makes vendor-neutral imaging software to standardize your workflow and simplify increasingly complex clinical scenarios. Leading global healthcare organizations use MIM® to give patients more precise, personalized care. https://www.mimsoftware.com/ The QA Specialist II role is a versatile and dynamic member of the Quality team.. The QA Specialist II will support Document Control, CAPA system, Risk Management, QMS activities and Complaints Management 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 QASII 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. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. This position is in GE Healthcare's MIM Software business which makes vendor-neutral imaging software to standardize your workflow and simplify increasingly complex clinical scenarios. Leading global healthcare organizations use MIM® to give patients more precise, personalized care. 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 (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.

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.
• Demonstrated ability to collaborate effectively and resolve conflicts.
• Exceptional critical thinking, problem-solving, root-cause analysis, and process improvement skills.
• Proficiency in managing multiple priorities effectively.
• 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.

Responsibilities

• Support and lead QMS activities related to Document Control, QMS management, CAPA, Risk Management and Complaints.
• 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 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level