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). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. 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
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
- Bachelor's 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 ISO 13485, 21 CFR 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 you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
Disclaimer:
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Additional Information
Relocation Assistance Provided: Yes
