GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation.
The Quality Assurance Manager is responsible for leading and driving a consistent message about GE Healthcare’s Quality vision and plans to execute while driving the definition of the quality objectives, metrics and reporting and operating mechanisms.
• Accountable for ensuring full quality and regulatory compliance of a facility, while driving process effectiveness and efficiency at the site
• Ensures site audit readiness and hosts the Quality System audits; prepares and executes Quality Management System reviews
• Has authority to stop production, issue product holds (stop orders), make decisions about budgets and people accountability, release products and sign off on project milestones (i.e. New Product Introduction)
• Maintains positive agency relationships-liaisons with regulatory agencies upon site inspections and participates in external technical forums
• Owns site compliance assessment and remediation plans while influencing site execution, functional policy, local research and development programs, and communications and training requirements for Quality matters
• Responsible for site education of non-Quality Assurance employees along with professional development of the site Quality Assurance team
·1. Bachelor’s degree (or high school diploma/GED plus 4 years working experience and understanding of product development, manufacturing, quality control and servicing in a medical device environment)
2. Significant Multi-Modality Sites: Minimum 5 years Quality Assurance/Regulatory Assurance experience in the medical device or pharmaceutical industry
3. Small and Simple Sites: Minimum 3 years Quality Assurance/Regulatory Assurance experience in the medical device or pharmaceutical industry
4. Minimum 1 year supervisory/management experience
5. Prior experience using word processing, spreadsheet, and presentation software
6. Demonstrated experience with regulations in the medical device and/or pharmaceutical industries
7. Ability to communicate using English (or local language)
Additional Eligibility Qualifications
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
1. 1. Proven managerial/leadership skills such as work planning, delegating & evaluating (if Site Mgr has direct reports)
2. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
3. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
4. Demonstrated collaboration, negotiation & conflict resolution skills
5. Excellent oral communication & report, business correspondence & procedure-writing skills
6. Proven mentoring and coaching abilities, demonstrated ability to motivate & inspire others
7. Proven leadership skills (experience successfully managing people/projects/issues)
8. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
9. Change agent with energy, passion & enthusiasm to drive change
10. Demonstrated effective interpersonal, teamwork & networking skills
11. Exceptional analytical, problem solving & root-cause analysis skills
12. Ability to make decisions, even when under pressure & take ownership for assigned projects and programs
13. Ability to multi-task & handle tasks with competing priorities effectively
14. Integrity: Accepting & adhering to high ethical, moral & personal values in decisions, communications, actions & when dealing with others
15. External Focus: Understanding customer needs, marketplace dynamics, industry trends, & the competitive landscape in the industry/function & considering the external impact of business activities & decisions on the external environment
16. Inclusiveness: Energizing others by building a connection with the team through personal involvement & trust & providing feedback & coaching to help develop others
17. Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly & concisely
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