Quality Lead Specialist

Title: Quality Lead Specialist Location: Remote

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 (Preventive). Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market. 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. 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.
• Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
• Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
• Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
• Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.

Required Qualifications

• Bachelor's Degree or a minimum of 9 years work experience.
• Minimum of 5 years working in a regulated medical device or pharmaceutical 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.
• Experience managing project teams.
• Demonstrated understanding or aptitude as it regards to primarily 21CFR212 as well as secondarily 21CFR211.
• Ability to travel domestically up to 40%.

Desired Characteristics

• Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
• Desired: Master's Degree or PhD in Engineering or Science or Pharmacy.
• Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry or experience in design engineering or manufacturing engineering in the medical device field.
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
• 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; & product quality improvement using tools such as six sigma, DFR, etc.

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. We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $106,400.00-$159,600.00 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 Apply tot his job Apply To this Job