Senior Associate Specialist Quality

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). Impacts quality of own work and the work of others on the team. Focused on execution of standard enabling activities / provision of advice subject to policy and work routines within an enabling discipline. There may be some latitude to rearrange the sequence to complete task / duties based on changing situations.

Job Description

Job Description

GEHC ONLY 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.

Required Qualifications

This role requires advanced experience in the Quality & Healthcare Quality. Knowledge level is comparable to a Bachelors degree from an accredited university or college ( or a high school diploma with relevant experience).

Minimum 5 years in Healthcare Quality and Regulatory

Desired Characteristics

Good Knowledge on Medical Device Standards and Regulations

Qualified internal auditor (ISO 9001 ISO 13485)

Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document plan market and execute programs. Established project management skills.

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.

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

Additional Information

Relocation Assistance Provided : Yes

Required Experience :

Senior IC

Key Skills

Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP

Employment Type : Full-Time

Experience : years

Vacancy : 1