Lead Quality Specialist

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. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the business.

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

• Responsible for the Quality Management System and Compliance activities for the site
• Creates a Quality culture by driving compliance activities and Quality metrics
• Ensures quality and regulatory compliance while driving process effectiveness and efficiency
• Utilize proven interpersonal skills to communicate with direct colleagues and the business. Provides informal guidance to team members. Concisely explains complex information to others.
• Operates with some autonomy, activities require professional judgment
• Utilizes professional experience, technical skills, and analytical thinking to provide compliance guidance to colleagues and assist with problem resolution. May use multiple internal sources outside of own team to arrive at decisions.
• Applies technical writing skill to maintain Quality procedures
• Represents GE HealthCare to external agencies

Required Qualifications

• Bachelor's Degree or a minimum of 4 years' work experience in Quality management
• Minimum of 1 year experience working in a regulated industry
• Ability to communicate effectively in English (both written and oral)
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications

Desired Characteristics

• Minimum of 3 years' experience in a regulated industry is preferred
• Demonstrated understanding or aptitude to understand ISO 13485 Medical Device QMS requirements and regulatory requirements
• Demonstrated knowledge of Quality Management System tools
• Experience performing internal audits and participating in external audits
• Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
• Demonstrated collaboration, negotiation & conflict resolution skills
• Exceptional analytical, problem solving & root-cause analysis skills
• Experience leading and implementing change
• 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
• 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
• Strong oral and written communication skills. Ability to document, plan, market, and execute programs. Established project management skills.
• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of QMS processes like Document controls, Corrective & Preventive Action (CAPA), complaints & risk management & product quality improvement

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 $84,800.00-$127,200.00 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