Job Description Summary

Job Description

Responsibilities

Quality Leadership & Culture

• Building and promoting a strong Quality culture across the business.

• Leading compliance activities for designated products sites or regions.

• Owning and maintaining the Total Quality Management System (TQMS).

• Driving quality objectives metrics reporting and operating mechanisms.

• Representing GE HealthCare in interactions with external agencies and regulatory bodies.

Quality Systems & Compliance

• Ensuring adherence to quality and regulatory requirements while improving process efficiency.

• Maintaining and enhance quality systems procedures and documentation.

• Monitoring quality performance and driving continuous improvement initiatives.

• Supporting the evolution of quality processes and standards across the organization.

Required Qualifications

• Bachelors degree.

• Experience in Quality Assurance Quality Engineering design engineering or manufacturing engineering within the medical device or pharmaceutical sector.

• Strong knowledge of Quality Management System tools continuous improvement methodologies and sitelevel product and process requirements.

• Strong ability to communicate effectively in English (written and verbal).

• Proficiency in MS Office applications (Word Excel PowerPoint databases).

• Experience in managing project teams.

• Demonstrated understandingor strong aptitude to learnMedical Device QMS and regulatory requirements including FDA 21 CFR 820 and ISO 13485.

Desired Characteristics

• Masters degree or PhD in Engineering or a technical discipline.

• Ability to communicate effectively across all organizational levels on topics such as:

  • design controls

  • design verification and validation

  • production and process controls

  • CAPA

  • complaints handling

  • risk management

  • product quality improvement (e.g. Six Sigma DFR).

• Demonstrated collaboration and conflictresolution skills.

• Experience with systems such as MyWorkShop TrackWise Pega Excel Software and strong project management capabilities.

• Understanding of:

  • product development lifecycle

  • design and document change control

  • process verification and validation

  • manufacturing and production process controls

  • service operations in a medical device environment.

• Knowledge of continuous improvement tools (e.g. DMAIC SPC Lean Six Sigma 5S).

• Experience in leading and implementing change.

• Experience conducting internal and external audits.

• Exceptional analytical problemsolving and rootcause analysis skills.

• Strong technical aptitude including the ability to read and interpret technical documentation and execute procedures.

• Experience

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 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.

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Additional Information