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GE HealthCare · 3 months ago

Design Control Engineer/Specialist

OH05-01-Beachwood-Science Park Drive

Full-time

Onsite

Senior Level

5+ years exp

GE HealthCare is a leading provider of vendor-neutral imaging software, aiming to enhance patient care through innovative solutions. The Design Control Specialist plays a crucial role in ensuring compliance with design, development, and transfer processes according to regulatory standards, while supporting quality management throughout the product lifecycle.

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Growth Opportunities

No H1B

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

Qualification

Design Control regulationsQuality Management SystemFDA CFR 21 820ISO 13485Risk ManagementQuality AssuranceSoftware as a Medical DeviceCritical thinkingProblem-solvingCollaboration

Required

Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of relevant work experience)

At least 5 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

Preferred

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

Benefits

Great work environment

Professional development

Challenging careers

Competitive compensation

Company

GE HealthCare

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GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.

Founded in 1892

Chicago, Illinois, USA

10001+ employees