About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
Role Summary: A Quality Assurance Senior Leader ensures product quality and process compliance to regulatory requirements for the designated product line(s) by managing the quality system design, controls and continuous improvement and establishing best practice standards in the development of new products.
• Managing quality systems, processes and procedures to assure product quality and safety.
• Assisting the Quality Assurance Site Manager in implementation of corrective actions that are raised by deviations, internal audit or regulatory inspection.
• Act as leader if the internal audit program
• Engaging strong interdepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs).
• Identifying, accessing and managing regulatory risk proactively and providing senior management with key data to help drive decisions.
• Liaising with internal personnel and external regulatory bodies to ensure appropriate input into regulatory strategy and ensure approval within milestone goals for submissions for assigned projects
• Working closely with other functional areas (e.g. Engineering, Manufacturing, Design) to ensure compliance to applicable regulations in the areas of Design, engineering and Manufacturing
• Leading and supporting continuous improvement activities assigned, which may include such areas as: Standards compliance, Risk management, and metrics development/implementation.
1. Bachelor's degree in Engineering, Medical Device Technology or Scientific Field and a minimum of 5 years work experience and understanding of product development, manufacturing, quality control and servicing in a medical equipment environment.
2. Minimum 3 years supervisory/management experience, including hiring, training, coaching and performance management activities.
3. Hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements.
4. Proven track record in performing external and internal audits.
5. Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations.
6. Effective report, business correspondence and procedure writing skills.
7. Good problem identification, multi-variable analysis and creative resolution aptitude.
8. Proven process development and project management skills.
9. Strong computer skills.
10. Ability to communicate using English
Quality Specific Goals:
1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as the application to this job type/position.
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required.
4. Ensure new product introductions and installed-base activities comply with existing and applicable global regulations.
5. Complete all management reviews in accordance with management controls procedures.
6. Drive timely closure of customer complaints, field actions, and quality system non-conformances in partnership with functional teams
1. Experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.
2. Six Sigma training and/or certification
3. Team player with a global mindset.
4. Change Acceleration skills.
5. Experience in building a Quality System from ground up.
6. Front line operational responsibility in Engineering, Manufacturing or Sourcing.
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