Perinatal Clinical Validation Specialist
GE HealthCare
**Job Description Summary**
The Clinical Validation Specialist will play a crucial role in executing product development assessments and pre-clinical validations. This role involves ensuring compliance with formal validation processes, including creating and maintaining validation documentation such as standard operating procedures (SOPs). The ideal candidate will be detail-oriented, with strong technical and analytical skills, and a commitment to quality.
**Job Description**
**Roles and Responsibilities**
+ **Validation Testing:** Conduct or oversee validation testing internally and in the field, ensuring adherence to established protocols.
+ Facilitate team understanding of user perspectives and current industry priorities, focusing on user wants and needs.
+ Provide valuable input and feedback on design processes, particularly during FHRAI and Vital Signs configuration.
+ Develop and update validation test cases and scenarios to ensure thorough testing and quality assurance.
+ **Quality Commitment:** Demonstrate a commitment to the quality policy and ensure that all validation activities meet high standards.
+ **Documentation:** Document work methods, procedures, and results accurately. Maintain a comprehensive library of validation documentation, scripts, and other related files.
+ **Program Enhancement:** Assist in revising and enhancing validation methods to align with corporate objectives.
+ **Defect Management:** Identify, document, and report defects according to established procedures.
+ **Project Oversight:** Oversee validation tasks and resources to ensure timely deployment within project timelines. Schedule, plan, and lead multiple projects of moderate scope and complexity.
+ **Client Support:** Provide assistance to clients during on-site validation activities and communicate validation status to clients and management.
+ **Cross Team Collaboration:** Provide support to other team members as needed to meet program goals and work closely with clients to measure the effectiveness of validation programs.
**Required Qualifications**
+ **Education:** Bachelor’s degree in clinical informatics or healthcare field i.e., nursing, laboratory science, Healthcare Science or a related field.
+ **Experience:** 5-10+ years experience in clinical validation of protocols and methods within a regulated environment.
**Desired Characteristics**
+ **Clinical Practices:** Knowledge of current healthcare setting practices and workflows across the Perinatal and Newborn care areas
+ **Industry Practices:** Knowledge of current industry practices and cGMP requirements related to validation tasks in a regulated environment.
+ **Technical Writing:** Proficient in technical writing with the ability to create clear, detailed documentation.
+ **Analytical Skills:** AWS, Advanced analytical skills with a demonstrated ability to solve complex problems.
+ **Communication Skills:** Strong written and verbal communication skills, with the ability to effectively communicate with clients and team members.
+ **Listening Skills:** Strong listening skills to ensure accurate understanding and execution of client and project requirements.
\#Onsite
\#Hybrid
\#LI-CH3
**Additional Information**
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:** No
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