Senior Quality Assurance Analyst

Job Description Summary

Join our dynamic QA team at GE HealthCare, where your expertise will directly influence the quality of our pharmaceutical manufacturing operations. As a Senior Quality Assurance Analyst, you will play a vital role in product releases, performing quality audits, and driving continuous improvement initiatives in a collaborative, fast-paced environment.

At GE HealthCare, we are innovators in medical technology and digital solutions, committed to creating a world where healthcare knows no bounds. By unlocking your ambition and transforming ideas into impactful realities, you'll contribute to a healthier world where every voice counts.

Key Responsibilities:

• Collaborate with Operations teams to ensure compliance with regulatory and quality standards during routine processes.

• Engage in and facilitate internal and external audits, ensuring thorough follow-ups are conducted.

• Execute quality assurance activities, including the revision of Standard Operating Procedures (SOPs) and the development of quality-related protocols.

• Review batch records and oversee the release of all products, including raw material batches.

• Analyze and address Non-Conformances related to product manufacturing and testing.

• Lead investigations for product complaints, ensuring comprehensive resolutions.

• Collect and present quality metrics as required by the organization.

• Support the implementation of new products to enhance site quality assurance.

• Participate in global QA initiatives to uphold standards across the business.

Qualifications/Requirements:

• Bachelor's degree or a high school diploma/GED with 7 years of relevant experience in a QA/RA or pharmaceutical/medical device environment.

• Minimum of 3 years of experience in pharmaceutical or medical device industries.

• Strong understanding of current Good Manufacturing Practices (cGMPs) for sterile product manufacturing.

• Willingness to work weekends on a rotating schedule.

Desired Skills:

• Experience with Corrective and Preventive Action (CAPA) systems, including complaint resolution.

• Strong analytical and problem-solving abilities; proficient in root-cause analysis.

• Exceptional written and verbal communication skills.

• Background in statistics, supplemented by relevant training.

• Experience in developing and tracking quality metrics.

• Familiarity with Continuous Improvement methodologies, particularly Six Sigma.

• Effective interpersonal skills and teamwork capabilities.

• Adept at managing multiple priorities and tasks effectively.

• Preferred: prior experience with GE HealthCare.

We expect all employees to embody our values: act with humility and build trust; lead with transparency; deliver with focus; and drive ownership—all while maintaining unwavering integrity.

Our competitive compensation and benefits package is designed to support your ambitions, providing you with the flexibility to turn your visions into reality. These include comprehensive medical, dental, and vision coverage, generous paid time off, a robust 401(k) plan, life and disability insurance, and tuition reimbursement.

Additional Information:

GE HealthCare values a diverse workforce and is committed to Equal Opportunity Employment. We make hiring decisions based on qualifications and without regard to race, color, religion, national origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other protected characteristics.

Applicants must be legally authorized to work in the United States. Employment offers are contingent upon successful drug screening where applicable.

Note: While GE HealthCare does not mandate COVID-19 vaccinations for all U.S. employees currently, some customer contracts may impose vaccination requirements for specific roles.