Senior Quality Engineer - SaMD

Job Description Summary

As a Senior Quality Engineer, you will provide quality engineering process support to GE HealthCare digital products in accordance with GE HealthCare medical device Quality Management System (QMS). You will be responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. You will work hands-on with quality and compliance activities around Software Development Projects.

At GE Healthcare, our machines, our software, our solutions, our services, and our people make a genuine difference to medical professionals and patients all over the world. That's because we never lose sight of what healthcare really needs-the human touch.

Job Description

Roles and 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

Required Qualifications:

• Bachelor's Degree in Engineering, Computer Science or equivalent.

• Minimum 5 years' experience in Quality Assurance / Regulatory Affairs.

• Minimum 3 years' experience in software within a regulated industry.

• 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.

Desired Characteristics:

• 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.

• ?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.

• 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.

We expect all employees to live and breathe our behaviors, to act with humility and build trust, lead with transparency, deliver with focus, and drive ownership - always unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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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: Yes