GE Jobs

Job Description Summary

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Has in-depth knowledge of best practices and how own area integrates with others; has working knowledge of competition and the factors that differentiate them in the market

Job Description

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.

Role Summary/Purpose

This position is responsible for ensuring region compliance and product quality for the AKA Region (ASEAN, Korea, Australia & New Zealand) while driving process effectiveness and efficiency. He/she is the voice of region product quality to Modality teams, supporting both the Region CEO and Service GMs. He / she is accountable to create and support a Quality culture across the Region by driving compliance activities via the total quality management system and Quality metrics.

Essential Responsibilities

1. Accountable for ensuring full quality compliance of the region, while driving process effectiveness and efficiency

2. Ensures audit readiness and hosts Quality System audits; prepares and executes Quality Management System reviews

3. Maintains and improves all aspects of Site Quality Planning, including but not limited to Corrective Action /

Preventive Action.

1. Oversees all Quality-related communications and training requirements for all region employees.

2. Establish mechanisms to continually articulate region product quality concerns and drive resolution with

modality and cross-functional teams.

1. Reports on Quality System effectiveness and Region Product Quality requirements to management team

including preparing and executing region Quality Management Reviews.

1. Drives the definition of site quality and region product quality objectives, metrics, reporting and operating

mechanisms.

1. Drive recall execution working with Service team and channel partners.

2. Owns region compliance assessment and remediation plans while influencing region execution, functional

policy, local research and development programs, and communications and training requirements for Quality

matters

1. Provides leadership and facilitates problem resolution, resource utilization, career counseling, mentoring and development of team members.

2. Maintains positive agency relationships-liaisons with regulatory agencies upon site inspections and

participates in external technical forums

1. Participates in selected global initiatives to share best practices and leverage synergies.

Qualifications / Requirements

1. Bachelor's Degree or a minimum of 10 years work experience.

2. Minimum of 5 years working in a regulated medical device or pharmaceutical industry.

3. Minimum of 1 year supervisory/management or project leadership experience

4. Ability to communicate effectively in English (both written and oral).

5. Demonstrated experience using word processing, spreadsheet, and presentation software.

6. Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory

requirements including but not limited to FDA CFR 21 820 and ISO 13485.

Desired Characteristics

1. Minimum of 5 years supervisory/management experience is preferred.

2. Proven process development and project management skills.

3. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance

4. Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.

5. Experience in a global, matrixed organization structure.

6. Excellent communication skills (written and oral)

7. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes

8. Demonstrated working knowledge to effectively communicate within all levels of the organization around concepts of Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.

9. Experience leading, implementing and accelerating change

10. Strong influencing, relationship building, mentoring & networking skills

11. Demonstrated collaboration & conflict resolution skills

12. Proven track record in performing & leading internal and external audits.

13. Exceptional analytical, problem solving & root-cause analysis skills

Additional Information

Relocation Assistance Provided: No