Job Description Summary

Job Description

Roles and Responsibilities

• Creates a Quality culture by driving compliance activities around a specific product site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives metrics reporting and operating mechanisms.

• Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.

• A job at this level is likely to be an individual contributor with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.

• Impacts projects processes and procedures in own field. The role operates with some autonomy but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment but may require more senior levels of guidance.

• Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

• Partners with Engineering and other cross functional teams to ensure adequate Design controls which includes verification and validation design transfer and design change activities.

• Supports program teams as a core team member to complete Quality and QMS deliverables for Programs.

• Ensures internal and external Audit readiness

  Takes part in evaluation of identified risks using risk management tools and deployment of required mitigation actions

• Partner with teams across regions to align packaging processes with QMS & regulatory requirements

Required Qualifications

• Bachelors degree in Engineering with minimum 10 years of experience as a Quality Assurance professional in Healthcare Industry

• Specialist in Design controls with exposure to Systems Engineering Validation & Verification Change deployment and Risk management Support and CAPA for design issues

• Hands on experience in review and approve packaging specifications test reports and validation protocols

• Good understanding of Quality Assurance activities and deliverables related to NPI / Programs.

• Experience in the application of QMS and Compliance requirements related to Design Controls in accordance with ISOCFR Part 820 IEC 62304 ISO 14971 EU MDR IMDR and other regulations

• Excellent Leadership Communication Collaboration and Negotiation skills

• Ability to deliver in a matrix organization which includes regional and global teams

• Demonstrated ability in application of problem-solving techniques and tools

• Result oriented with customer centric mindset

Desired Characteristics

• Experience with ISO/ MDSAP/Notified Body audits FDA Inspections and other

• Professional certification such as ASQ Six Sigma LEAN manufacturing or other

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.

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.

Disclaimer: GE HealthCare will never ask for payment to process documents refer you to a third party to process applications or visas or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare. If you suspect you have received a fraudulent call please fill out the form below: Information