Design Quality Engineer

GE HealthCare; Beachwood (OH); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Professional development

Challenging careers

Competitive compensation

Job summary

A leading healthcare technology company located in Beachwood, Ohio is seeking a Quality Assurance expert with a minimum of 6 years of experience in a regulated industry, preferably in Medical Devices. The position demands compliance with FDA Design Control regulations and ISO standards. Responsibilities include managing design quality systems, conducting reviews, and supporting risk management activities. A competitive compensation package and professional development opportunities are offered, reflecting the company's commitment to employee growth.

Qualifications

• Minimum 6 years of experience in Quality Assurance within a regulated industry.
• Understanding of FDA CFR 21 820 and ISO 13485 requirements.
• Experience with Software as a Medical Device (SaMD) preferred.

Responsibilities

• Be a subject matter expert in Design Control regulations.
• Develop and manage design quality systems.
• Perform reviews of design projects and deliverables.

Skills

Quality Management Systems

Regulatory compliance

Risk Management

Quality Assurance

Design Control regulations

Medical Device regulations

Education

Bachelor's degree

Job description

Job Description Summary

GE Healthcare's MIM Software business develops vendor-neutral imaging software that standardizes workflow and simplifies increasingly complex clinical scenarios. Leading global healthcare organizations use MIM® to give patients more precise, personalized care.

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.
• Ensure 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.
• Serve 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.

Benefits

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.

Legal and EEO Statement

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

No