134 applicants

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Company

Original Job Post

GE HealthCare · 6 days ago

Quality Engineer - SaMD

United States

Full-time

Remote

Mid Level

$82K/yr - $124K/yr

3+ years exp

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Responsibilities

Guide teams in creating software development plans, design change plans, design inputs, verification and validation plans and reports, risk management documentation, defect resolution, SDLC deliverables, design reviews, non-product software validation.

Participate in core teams as the quality representative, and review and approve program documentation.

Ensure program compliance to GE work instructions and applicable regulations such as ISO 13485, ISO 14971, IEC 62304, 21 CFR Part 820, MDD, MDR.

Support nonconformance evaluations, investigations, CAPA action plans, effectiveness checks.

Participate in internal audits and support internal and external audits.

Perform other duties as assigned.

Qualification

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Quality AssuranceRegulatory AffairsAgileLeanProject ManagementMedical DeviceQMSFDA CFR 21 820ISO 13485Software developmentSDLCDesign controlsProcess verificationValidation methodologiesManufacturing process controlHealthcare software developmentGlobal working environmentChange managementInternal auditsExternal auditsRegulatory experienceRegulator interfacingCommunicationLeadershipProblem-solving

Required

Bachelor’s degree in engineering, computer science, or equivalent.

Minimum 3 years’ experience in Quality Assurance/Regulatory Affairs.

Minimum 3 years’ experience in software within a regulated industry.

Demonstrate experience with Agile/Lean software development methods.

Previous project management experience.

Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.

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.

Preferred

Practical knowledge of software development and familiarity with Software Development Lifecycle (SDLC), design change and document change control, process verification and validation methodologies, manufacturing/production process control methodologies in medical device or healthcare software development environment.

Demonstrated expertise with effectively communicating within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management.

Experience in a global working environment.

Experience leading and implementing change. Experience performing internal audits and participating in external audits.

Demonstrate technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.

Benefits

Medical insurance

Dental insurance

Vision insurance

Paid time off

401(k) plan with employee and company contribution opportunities

Life insurance

Disability insurance

Accident insurance

Tuition reimbursement

Company

GE HealthCare

Glassdoor

4.2

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

10,001+ employees