Design Quality Engineer job opportunity at GE HealthCare.

Home Jobs In United States Of America Tag: Job Design Quality Engineer position at GE HealthCare


DatePosted 30 Days Ago bot
GE HealthCare Design Quality Engineer
Experience: 6-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeOND
loacation OH05-01-Beachwood-Science Park Drive, United States Of America
loacation OH05-01-Beachw..........United States Of America

Job Description Summary 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 Design Control Specialist is a detail-oriented and collaborative member of the Quality team. The primary responsibility is to ensure an effective design, development, and transfer process that adheres to applicable FDA, EU regulations, ISO 13485:2016, and other governing regulations applicable to MIM Software. Provide quality support for new product introductions and ongoing projects throughout the product development lifecycle. Provide Design Quality expertise in early to late-stage product development. The Design Control Specialist is responsible for adherence to the MIM software Quality Management System. As a critical member of the NPI core 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. Job Description Roles and Responsibilities Be a subject matter expert in Design Control regulations and applicable standards. Develop and manage design and development quality systems, and provide direction, support, and oversight of the program. Ensures building compliant new product development processes with adherence to FDA Design Control requirements and Risk Management ISO standards.  Perform a review of design projects and design control procedural deliverable requirements. Participate in risk assessments, risk mitigation strategies and risk management plans, provide review/approval as needed. Provide design control lifecycle, procedure, and policy training. Support product design related investigation of quality events such as nonconformities, CAPAs, customer complaints, etc. Serves as Quality lead on design change control submissions. Author and review Design Control documentation to support regulatory filings 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. Required Qualifications Bachelor's degree from an accredited university or college. At least 6 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 Experience in Quality Assurance or Quality Engineering within the Medical Device or Pharmaceutical industry, or in Design Engineering in the Software as a Medical Device field (SaMD).  Demonstrated expertise in Medical Device Design Controls, Production and Process Controls, and Installation and Servicing. Strong influencing skills and ability to clearly communicate the requirements of Design Controls, Design Verification and Validation, Production and Process Controls, Corrective & Preventive Action (CAPA), and Risk Management across functions. Demonstrated ability to collaborate effectively and resolve conflicts. Capability to lead, develop, communicate, and implement compliance goals during crises. Exceptional critical thinking, problem-solving, root-cause analysis, and process improvement skills. Proficiency in managing multiple priorities effectively. Note: To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years' experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

 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 have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No

Other Ai Matches

Hardware Integration Manager Applicants are expected to have a solid experience in handling Job related tasks
Sr. Software Engineer Applicants are expected to have a solid experience in handling Job related tasks
Customs Compliance Leader - Europe Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Customer Supply Excellence Manager Applicants are expected to have a solid experience in handling Job related tasks
Production Team Leader Applicants are expected to have a solid experience in handling Job related tasks
Director - AI Science Applicants are expected to have a solid experience in handling Job related tasks
Lead Manufacturing Specialist - Prod Process and Equipment (multiple positions) Applicants are expected to have a solid experience in handling Job related tasks
Estágio em Planejamento Financeiro Applicants are expected to have a solid experience in handling Job related tasks
Advanced Manufacturing Engineer – Digital Supply Chain Applicants are expected to have a solid experience in handling Job related tasks
Service Account Leader – HCS (Wallonia & Luxembourg) Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Clinical Applications Specialist - Anesthesia & Respiratory Care Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Global Head, Regulatory Affairs – Labeling (PDx) Applicants are expected to have a solid experience in handling Regulatory Affairs – Labeling (PDx) related tasks
remote-jobserver Remote
Capital Equipment Deal Hub Architect (Commercial) Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Field Service Engineer 2 - So. Illinois - KY Applicants are expected to have a solid experience in handling Job related tasks
Staff AI Application Engineer, Enterprise AI Applicants are expected to have a solid experience in handling Enterprise AI related tasks
National Sales Manager Applicants are expected to have a solid experience in handling Job related tasks
Staff Technical Project Manager, CT Applicants are expected to have a solid experience in handling CT related tasks
Senior Lifecycle Operations Engineer Applicants are expected to have a solid experience in handling Job related tasks
Field Service Engineer- Toscana Applicants are expected to have a solid experience in handling Job related tasks
Staff Software Engineer Applicants are expected to have a solid experience in handling Job related tasks
Field Service Engineer（千葉） Applicants are expected to have a solid experience in handling Job related tasks
Clinical Application Manager - Voluson Applicants are expected to have a solid experience in handling Job related tasks
Early Career Trainee, Diagnostics Imaging Applicants are expected to have a solid experience in handling Diagnostics Imaging related tasks