Director, Quality, Global Installation Service

Job Description Summary

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards. Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.

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.

Job Description

Roles and Responsibilities

• Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.

• Requires specialized depth and/or breadth of expertise within their discipline. May require strong commercial awareness, and is expected to influence the development of strategy within own area, including control of resources and influences policy formulation.

• May lead functional teams or projects with minimal resource requirements, risk, and/or complexity. Communicates difficult concepts and may influence others' options on particular topics. May guide others to consider a different point of view.

• Impacts the team's ability to achieve service, quality and timeliness of objectives. Work is subject to functional policy objectives. Regularly advises management in the function and/or in the business. Has a supportive role in decision making about important subjects. High levels of evaluative judgment are required to achieve outcomes required.

• Uses high level of judgment to make decisions and handle complex tasks or problems that impact the function. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.

Required Qualifications

• Master's Degree and a minimum of 5 years' experience in the medical device industry; or Bachelor's Degree and a minimum of 10 years' experience in the medical device industry; or will consider a High School Diploma and a minimum of 15 years' of progressive responsibility in the medical device industry.

• Minimum of 5 years' Experience driving Global programs to resolve quality compliance issues (directly).

• Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.

Desired Characteristics

• Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects. Ability to document, plan, market, and execute programs. Established project management skills.

• Experience in a global, matrixed organization structure

• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes

• Experience in developing, implementing and maintaining quality system processes and driving improvements to processes.

• Demonstrated working knowledge to effectively communicate within all levels of the organization around concepts of design controls, servicing and installation, Corrective & Preventive Action (CAPA), complaints & risk management, and auditing

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For U.S. based positions only, the pay range for this position is $136,000.00-$204,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

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