Lead Quality Specialist

Job Description SummaryGE 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.
Develop and maintain systems, rules, and processes to ensure fulfillment of current regulations / industry practices and internal 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 area.

Job Description

Roles and Responsibilities

• Leading the development and maintenance of Quality System metrics
• Leading the preparation and execution of Quality Management Reviews at a site level
• Utilize technical expertise and judgement to solve problems.
• Actively participate in complaint handling as a quality expert.
• Provide support to routine activities, projects, development and training relevant to area of expertise.
• Support continuous improvement activities with regard to areas of responsibility.
• Assess quality impact on product and manufacturing processes. This may include acting as quality expert and approval/authorization of technical product related documentation.
• Analyze & communicate proposed, new or changing requirements & devise strategies for their implementation, ensuring business goals are met.
• Translating new industry trends and requirements into business policies and practices.
• Identifying, assessing and managing risk proactively and providing senior management with key data to help drive decisions.
• Providing support to team in relation to key Electronic Management Systems.
• Maintain & keep quality procedures up to date and reflective of regulatory requirements.
• Assist in validation activities in relation to equipment, processes and/or computer systems.
• Represent QA on development projects and advise on the adequacy of validation of facilities, equipment and new products/processes, including designing strategies to ensure adequate data is gathered.

• Conducts Quality System audits of specialist area; prepares and executes Quality Management System (QMS) reviews, as applicable.
• Participates in site inspections.
• Owns compliance assessment and remediation plans while influencing execution, communications and training for Quality matters.
• Responsible for coordinating and performing training relative to the specialist area, QMS principles and on the global QMS procedures as required.
• Secure that a QMS system is operational and support implementation of the QMS.

Required Qualifications

• B.S. Degree in business or technical field.
• 3 years experience in a medical device or pharmaceutical industry.
• 3 years experience with CA/PA systems, including complaint handling.
• 3 years experience applying regulations (including FDA QSRs, ISO13485).
• Proficient with MS Office word processing, spreadsheet, presentation, and database applications.
• Ability to identify root cause of problem and creatively problem solve to gain resolution.
• Ability to communicate effectively in English (both written and oral).
• Ability to work independently in fast-paced environment with little supervision.
• Ability to adapt to constant change and influence positive change effectively.
• Team-oriented and responsive to customer needs.
• Quality-Focused, Attentive to Detail and Results-Oriented.

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.
• Experience developing and tracking quality metrics
• Familiar with Continuous Improvement methodologies, including Six Sigma

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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.

Behaviors

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.

Total Rewards

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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Additional Information