"Alerted.org

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). 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.

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

+ Develop, implement, and maintain quality assurance protocols and procedures to ensure compliance with regulatory standards.

+ Conduct thorough inspections and audits of manufacturing processes to identify areas for improvement and ensure product quality.

+ Collaborate with cross-functional teams, including R&D, production, and regulatory affairs, to support product development and production transfer activities.

+ Ensure that design controls are effectively applied throughout the product lifecycle, from concept to commercialization.

+ Manage Design and Production transfer activities.

+ Investigate and resolve quality issues, including non-conformances and customer complaints, using root cause analysis and corrective/preventive actions.

+ Prepare and maintain detailed documentation, including quality plans, inspection reports, and validation protocols.

+ Stay up-to-date with industry regulations and standards, and ensure that the company remains compliant with all relevant requirements.

+ Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

Required Qualifications

+ Bachelor's Degree or a minimum of 7 years' work experience

+ Minimum of 3 years of experience in a regulated industry, preferably within the medical device industry.

+ In-depth knowledge of design controls and production transfers.

+ Strong analytical and problem-solving skills, with the ability to identify and address quality issues effectively.

+ Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.

+ Detail-oriented and highly organized, with the ability to manage multiple projects simultaneously.

+ Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Desired Characteristics

+ Strong oral and written communication skills.

+ Demonstrated ability to analyze and resolve problems.

+ Ability to document, plan, market, and execute programs.

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.

\#LI-MC2

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) . 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:** Yes