Quality Assurance Technician

GE HealthCare; Waukesha (WI); On-site; USD 42,000 - 64,000; Full time

Job summary

GE HealthCare in Waukesha, WI seeks a Quality Administrative Specialist to support product release by reviewing device history records and quality docs, and to drive continuous improvement in medical device manufacturing. The role is 100% onsite and requires detail-oriented, compliant documentation and cross-functional support.

You will review records, assist CAPA and QMS tasks, coordinate with operations, and ensure timely release of products while maintaining clear communication and robust

Qualifications

• High School Diploma/Certificate or relevant technical work experience.
• 2+ years of experience in a manufacturing environment.
• Proficient in MS Excel, Word, Outlook, and Teams.
• Strong verbal and written communication skills in English.

Responsibilities

• Review production records/documentation and labeling and approve product release.
• Support timely review and release of product to market.
• Liaise with Operations to ensure regulatory and quality requirements are met.
• Respond to quality-related inquiries from other departments.
• Provide QA support for QMS tasks and documentation (CAPA, concessions/deviations, training, audits).

Skills

Attention to Detail

Analytical Skills

Problem-Solving Skills

Communication skills

Education

High School Diploma/Certificate

Tools

MS Excel

MS Word

MS Outlook

Teams

Job description

Job Description Summary

This position within the Quality Department supports product release of medical devices through the review of the product and key documentation (device history record) and facilitates continuous improvement of medical device manufacturing. Further, this role provides administrative task support to the quality team and site in terms of compliance and product quality documentation or actions.

Job Description Summary

This position within the Quality Department supports product release of medical devices through the review of the product and key documentation (device history record) and facilitates continuous improvement of medical device manufacturing. Further, this role provides administrative task support to the quality team and site in terms of compliance and product quality documentation or actions.

This position is 100% onsite in Waukesha, WI

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. 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.

Responsibilities

Job Description

• Review production records/documentation and labeling and approve the release of product which includes physically checking and tagging the product on the manufacturing floor.
• Support the timely review and release of product to market
• Liaise with Operations personnel to ensure regulatory and quality requirements are met and understood within operations to support the final acceptance of product
• Respond to quality related inquiries from other departments
• QA support for Quality Management System (QMS) tasks and documentation (including but not limited to concessions/deviations, corrections/corrective action (CAPA), training management, audits, etc.)

Qualifications

• High School Diploma/Certificate or relevant technical work experience
• 2+ years of experience in a manufacturing environment
• Intermediate or Advanced User of MS Excel / Word / Outlook / Teams
• Strong verbal and written communication skills - must fluently read, speak, and write in English
• Attention to Detail: Precision in reviewing documents and identifying discrepancies
• Analytical Skills: Ability to analyze data and records to ensure compliance with standards and regulations
• Problem-Solving Skills: Identifying and resolving issues in documentation and processes
• Available to work Monday through Friday 8:30 AM to 5:00 PM
• Available to work weekday and weekend overtime (as needed)
• Ability to move about the facility for extended periods of time
• Ability to lift, carry, push, or pull up to 10 pounds regularly and 45 pounds occasionally

Desired Characteristics

• Highly organized and motivated
• Strong at working independently and managing time
• Experience using AI prompts
• Excellent interpersonal skills
• Familiarity with eDHR/electronic records systems
• Familiar with Lean principles to drive standard work and continuous improvements

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.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

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