Job Description Summary

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements for medical devices and pharma products distributed by PDx. 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.

Job Description

Roles and Responsibilities

• GEHC ONLY Creates a Quality culture by driving compliance activities around a Life Sciences 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.

• Demonstrated understanding or aptitude to understand Pharmaceutical and Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820,ISO 13485, Good Distribution Practices (GDP), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP).

• Hands-on experience with FDA, QSR, ISO, MDD, GDP, GLP, GMP and/or other local or international quality systems requirements.

• 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

• For roles outside of the USA- This role requires advanced experience in the Quality & Life Sciences Quality. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).
• For roles in USA - Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in Job Family Group(s)/Function(s)).

Desired Characteristics

• 
  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.
   

  Note:

  
  To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years' experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.

Additional Information