Job Description Summary
The Quality Assurance Leader is responsible for the zones compliance to GEHC QMS and the local regulatory requirements. She/he is responsible for the quality management system controls and continuous improvement and establishing best practice standards to assure product safety and quality.
Job Description
Description:
The Quality Assurance Leader is responsible for the zones compliance to GEHC QMS and the local regulatory requirements. She/he is responsible for the quality management system controls and continuous improvement and establishing best practice standards to assure product safety and quality.
Key responsibilities include:
- Participate in the development and maintenance of the region Quality Management System (QMS) and relevant processes to assure product quality and safety.
- Ensure company procedures and proper documentation practices are followed per GE Healthcare QMS requirements
- Attend region/zone QMS and metrics reviews with service and business management functions
- Coach and mentor functional teams on the development maintenance and implementation of local procedures (if any)
- Provide advice & counsel the business managers in the zone with QMS related processes
- Assist the Quality Assurance Site Manager (when applicable) in preparation for internal/external audits and implementation of corrective actions to address non-conformities.
- Work closely with other functional areas (e.g. Marketing Engineering Service) to ensure compliance to applicable regulations
- Lead and support continuous improvement activities assigned which may include such areas as: ISO standards compliance Risk management and metrics development/implementation.
Qualifications:
- BachelorsdegreeinEngineeringMedicalDeviceTechnologyorScientificField
- Experience and understanding of product developmentmanufacturing quality control and servicing in themedicalequipmentor pharmaceutical industry
- Knowledge and experience with ISO9001 and 13485 and/or other international quality systems requirements
- Proven trackrecordinperformingexternalandinternalaudits preferred.
- Abilityto readanalyze andinterpretbusinessplanstechnicalproceduresandgovernmental regulations
- Strong computerskills
- Ability to communicate fluently in English
- Front lineoperationalresponsibility inField Service but also support technology transfer projects guide/support sourcing for compliant purchases and support supplier quality initiativeswhere necessary
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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.
Behaviors
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.
Total Rewards
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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
#LI-FG1
#LI-Hybrid
Additional Information
Relocation Assistance Provided: No
Job Description SummaryThe Quality Assurance Leader is responsible for the zones compliance to GEHC QMS and the local regulatory requirements. She/he is responsible for the quality management system controls and continuous improvement and establishing best practice standards to assure product safety...
Job Description Summary
The Quality Assurance Leader is responsible for the zones compliance to GEHC QMS and the local regulatory requirements. She/he is responsible for the quality management system controls and continuous improvement and establishing best practice standards to assure product safety and quality.
Job Description
Description:
The Quality Assurance Leader is responsible for the zones compliance to GEHC QMS and the local regulatory requirements. She/he is responsible for the quality management system controls and continuous improvement and establishing best practice standards to assure product safety and quality.
Key responsibilities include:
- Participate in the development and maintenance of the region Quality Management System (QMS) and relevant processes to assure product quality and safety.
- Ensure company procedures and proper documentation practices are followed per GE Healthcare QMS requirements
- Attend region/zone QMS and metrics reviews with service and business management functions
- Coach and mentor functional teams on the development maintenance and implementation of local procedures (if any)
- Provide advice & counsel the business managers in the zone with QMS related processes
- Assist the Quality Assurance Site Manager (when applicable) in preparation for internal/external audits and implementation of corrective actions to address non-conformities.
- Work closely with other functional areas (e.g. Marketing Engineering Service) to ensure compliance to applicable regulations
- Lead and support continuous improvement activities assigned which may include such areas as: ISO standards compliance Risk management and metrics development/implementation.
Qualifications:
- BachelorsdegreeinEngineeringMedicalDeviceTechnologyorScientificField
- Experience and understanding of product developmentmanufacturing quality control and servicing in themedicalequipmentor pharmaceutical industry
- Knowledge and experience with ISO9001 and 13485 and/or other international quality systems requirements
- Proven trackrecordinperformingexternalandinternalaudits preferred.
- Abilityto readanalyze andinterpretbusinessplanstechnicalproceduresandgovernmental regulations
- Strong computerskills
- Ability to communicate fluently in English
- Front lineoperationalresponsibility inField Service but also support technology transfer projects guide/support sourcing for compliant purchases and support supplier quality initiativeswhere necessary
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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.
Behaviors
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.
Total Rewards
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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
#LI-FG1
#LI-Hybrid
Additional Information
Relocation Assistance Provided: No
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