Description

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 of relevant experience in Quality Management or a related field
Hands-on experience managing a Quality Management System (QMS), including internal audits, document control, and procedural updates
Experience working in a regulated manufacturing environment (ISO standards), ideally within medical devices or related industries
Experience working in a clean room and/or semiconductor environment
Experience supporting or working with complex product lines (e.g., digital X-ray detectors or similar technologies)
Demonstrated ability to work effectively in a smaller, fast-paced team environment where individuals take on multiple responsibilities
Strong collaboration skills with the ability to partner cross-functionally and drive alignment across teams
Effective written and verbal communication skills, including the ability to explain complex concepts clearly
Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, etc.)
Ability to manage multiple priorities and operate with strong self-direction and accountability

Desired Characteristics

3+ years of experience in a regulated industry
Familiarity with ISO 13485 and medical device Quality Management System requirements
Experience with key quality processes such as CAPA, internal/external audits, and root cause analysis
Exposure to product lifecycle activities, including design changes, validation, and process control methodologies
Experience interfacing with regulatory bodies or supporting inspections
Strong analytical and problem-solving skills with the ability to identify and resolve complex issues
Demonstrated ability to contribute to or lead process improvements or change initiatives

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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 $89,600.00-$134,400.00 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

Lead Quality Specialist

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Job Description

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