Quality Assurance Manufacturing

State College, PA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

The job posting is outdated and position may be filled

Job Summary

Job Description Summary

This position is responsible for supporting manufacturing and/or engineering processes in accordance with documented procedures and practices. This role supports the development implementation improvement and continuous reinforcement of established Quality Assurance fundamental practices. The role involves hands-on work in the areas of incoming and in process inspections CAPA and internal audits supporting manufacturing and distribution at our BK Medical site in State College Pennsylvania.

BK Medical is committed to designing active imaging systems that help surgeons visualize anatomy and lesions guide interventions and navigate inside the human body. Our mission at BK is to change the standard of care in surgical interventions with real-time visual guidance giving surgeons the information needed to immediately make critical decisions.

Now BK Medical is advancing its mission with GE Healthcare. Together we will reach more customers and continue to empower surgeons to make critical decisions that allow for better care faster procedures and reduced complications.

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

Role Responsibilities

Create a Quality culture by driving compliance activities.
Ensure ongoing patient safety regulatory compliance and enable commercial delivery of GE Healthcare products by providing total quality management system process support in accordance with documented procedures and practices.
Responsible for implementing and continuously improving the quality management system in the area of production and process controls. Ensures quality and regulatory compliance while driving process effectiveness and efficiency.
Assist with BK Medical QMS integration into the GE Healthcare Global QMS.
Support the evolution of the quality culture which includes executing and driving quality objectives metrics reporting and operating mechanisms.
Performs internal audits supports external audits and promotes product and process improvements through root cause analysis and CAPA.
Support risk management tools and aids for use by the organization in accordance with documented procedures including but not limited to PFMEA Fault Tree Analysis Failure Mode Analysis etc.

Required Qualifications

Bachelors degree in Engineering or a related STEM degree from an accredited university or High School Diploma/Local equivalent (GED) with a Minimum of 3 years experience in a quality role.
Proficient in Microsoft office (Word Excel PowerPoint).
Strong oral and written communication skills.

Desired Characteristics

Experience in a Regulated Industry and/or demonstrated understanding of Medical Device quality management systems regulations and international standards including but not limited to FDA 21 CFR 820 European Medical Device Regulation and ISO 13485.
Demonstrated ability to analyze and resolve problems.
Ability to document plan market and execute programs. Established project management skills.
Trained Internal Auditor.

#LI-SAM1

#LI-ONSITE

#LI-PA

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 anEqual 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

Job Description SummaryThis position is responsible for supporting manufacturing and/or engineering processes in accordance with documented procedures and practices. This role supports the development implementation improvement and continuous reinforcement of established Quality Assurance fundamenta...

Job Description Summary

Job Description

Role Responsibilities

Create a Quality culture by driving compliance activities.
Ensure ongoing patient safety regulatory compliance and enable commercial delivery of GE Healthcare products by providing total quality management system process support in accordance with documented procedures and practices.
Responsible for implementing and continuously improving the quality management system in the area of production and process controls. Ensures quality and regulatory compliance while driving process effectiveness and efficiency.
Assist with BK Medical QMS integration into the GE Healthcare Global QMS.
Support the evolution of the quality culture which includes executing and driving quality objectives metrics reporting and operating mechanisms.
Performs internal audits supports external audits and promotes product and process improvements through root cause analysis and CAPA.
Support risk management tools and aids for use by the organization in accordance with documented procedures including but not limited to PFMEA Fault Tree Analysis Failure Mode Analysis etc.

Required Qualifications

Bachelors degree in Engineering or a related STEM degree from an accredited university or High School Diploma/Local equivalent (GED) with a Minimum of 3 years experience in a quality role.
Proficient in Microsoft office (Word Excel PowerPoint).
Strong oral and written communication skills.

Desired Characteristics

Experience in a Regulated Industry and/or demonstrated understanding of Medical Device quality management systems regulations and international standards including but not limited to FDA 21 CFR 820 European Medical Device Regulation and ISO 13485.
Demonstrated ability to analyze and resolve problems.
Ability to document plan market and execute programs. Established project management skills.
Trained Internal Auditor.

#LI-SAM1

#LI-ONSITE

#LI-PA

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

Additional Information

Relocation Assistance Provided: No

Key Skills

Test Cases
SQL
Quality Assurance
Agile
TFS
Jira
Software Testing
Test Automation
Cucumber
QA/QC
SDLC
Selenium

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About Company

GE HealthCare

As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence With over 100 years of healthc ... View more

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