Senior Director, Quality, Digital

Job Description Summary

This people-leader position will be responsible for Quality Assurance activities in support of the STO organization within Digital Quality, in all pertinent areas of the Quality System. The role will be responsible to develop and maintain systems, rules, and processes to ensure fulfillment of internal and external quality requirements. Specifically, working closely with the business to develop and sustain Digital-specific processes and ensure consistent application of such processes. Ensures that projects, processes and products are capable and will meet specified standards. The role will need to Interpret simple internal and external business challenges and recommends best practices to improve products, processes or services within Digital quality. 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 for the STO organization. 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.

• People leader with senior level direct reports. Deep expertise within quality to drive compliance and continuous improvement in Digital Quality processes. Provides professional or thought leadership. Influences policy and ensures delivery within Digital Quality, linking with other functions of the organization.

• Will lead functional teams or projects with moderate to high resource requirements, risk, and/or complexity to drive continuous improvement within the quality system. Presents business solutions to leaders in the area of quality including New Product Introductions, Recalls, CAPA, Quality Metrics, etc. Communicates complex messages and negotiates mainly internally with others to adopt a different point of view. Influences peers to take action and may negotiate with external partners, vendors, or customers.

• The role influences policy/operating guidelines impacting Digital Quality.

• Uses high level of judgment to make decisions and handle complex tasks or problems that impact Quality. 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

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

• Minimum 10 years' experience in Quality Assurance / Regulatory Affairs.

• Minimum of 2 years' experience as a people leader.

• Experience with Agile/Lean software development methods.

• Ability to effectively communicate technical information in English (both written and oral).

• 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

• Strong leadership and communication skills. Previous project management experience is preferred. Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485. Demonstrated expertise to effectively communicate 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.

• Demonstrated collaboration, negotiation & conflict resolution skills. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance. Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment. Experience in a global working environment.

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

• Exceptional analytical, problem solving & root-cause analysis skills. Ability to multi-task & handle tasks with competing priorities effectively. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.

• Experience working and communicating directly with external medical device 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 with 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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For U.S. based positions only, the pay range for this position is $160,720.00-$241,080.00 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