Quality Assurance Technician

HC1316 GE Precision Healthcare LLC; West Milwaukee (WI); On-site; USD 42,000 - 54,000; Full time

Job summary

GE HealthCare is seeking a QA Support Administrator to assist the QA Department with batch release and compliance activities for medical devices. The role involves compiling internal and external reports and supporting regulatory documentation processes.

The candidate will work Monday through Friday, 6am–3pm, in a role requiring attention to detail, strong communication, and familiarity with ERP systems. No visa sponsorship is available for this opening.

Qualifications

• High School Diploma or relevant work experience.
• Proficiency with Excel and Word.
• Familiarity with Electronic Management Systems.
• Strong verbal and written communication; detail-oriented.
• Highly organized with good interpersonal skills.

Responsibilities

• QA support for product release.
• Review production documentation and assist with batch release procedures.
• QA support for registration activities of regulatory documentation.
• Support the compilation of QA monthly reports.
• Conduct QA activities including ERP system usage and issuance of protocols/reports.
• Liaise with Operations to ensure regulatory and quality requirements are met.
• Support the deviation / corrective action program.
• Respond to routine quality-related queries from other departments.

Skills

Excel

Word

Verbal communication

Written communication

Attention to detail

Education

High School Diploma

Tools

Electronic Management Systems

eDHR system

Job description

Job Description Summary

This position involves working within the QA Department as a support to the batch release and compliance functions for medical devices. This role provides administrative support to the department in terms of compilation of the various reports required both internally within the department and externally. Typical schedule is Monday - Friday from 6am - 3pm.

Essential Responsibilities

• QA support for product release.
• Review production documentation and assist with batch release procedures which requires repetitive lifting (approximately 20 lbs), bending, and/or twisting.
• QA support for registration activities of regulatory documentation.
• Support the Compilation of QA Monthly Reports.
• Conducting QA activities including relevant enterprise resource planning (ERP) system and the issuance of protocols, reports etc.
• Liaise with Operations personnel to ensure regulatory and quality requirements are met and understood during routine operations.
• Supporting the ongoing deviation / corrective action program.
• Responding to routine quality related queries from other departments.

Qualifications / Requirements

• High School Diploma/ Certificate or relevant work experience.
• Knowledge of relevant Excel / Word packages and familiarity with Electronic Management Systems.
• Strong verbal and written skills.
• Attention to detail.

Desired Characteristics

• Highly organized and motivated.
• Excellent interpersonal skills.
• Familiarity with eDHR system.

Additional Information

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

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.