General Electric Senior Quality Assurance Manager in Haifa, Israel
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.
This position is responsible for ensuring quality and regulatory compliance of a large and/or multi-modality Molecular Imaging (NM&PET) facility, while driving process effectiveness and efficiency. He/she represents GE Healthcare to external agencies and champions the evolution of the quality culture for the site which includes executing and driving site quality objectives, metrics, 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 and improves all aspects of Site Quality Planning.
Oversees all Quality-related communications and training requirements for all site employees.
Maintains positive agency relationships-liaisons with regulatory agencies upon site inspections and participates in external technical forums
Ensures site audit readiness and hosting Quality System audits and inspections.
Oversees the Corrective Action / Preventive Action activities and Complaint Handling Programs
Reports on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews.
Drives the definition of site quality objectives, metrics, reporting and operating mechanisms.
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
Influences site compliance to Quality policy, Quality Management System procedures, and Quality Star guidelines
Influences quality system metrics such as Corrective and Preventive Action, training metrics, completion and complaint resolution metrics
If managing a team, provides leadership and facilitates problem resolution, resource utilization, career counseling, mentoring and development of team members.
Participates in selected global initiatives to share best practices and leverage quality synergies.
Supports local NPI programs and quality issue resolution.
Acts as Management Representative for Quality at the Site.
Bachelor's Degree or a minimum of 10 years work experience .
Minimum of 5 years working in a regulated medical device or pharmaceutical industry.
Minimum of 3 years of management experience
Ability to communicate effectively in English (both written and oral).
Demonstrated experience using word processing, spreadsheet, and presentation software.
Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
Hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements.
Proven collaboration & conflict resolution skills
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 they apply 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
Minimum of 5 years management experience is preferred.
Proven process development and project management skills.
Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.
Experience in a global, matrixed organization structure.
Excellent communication skills (written and oral)
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
Demonstrated working knowledge 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.
Experience leading, implementing and accelerating change
Strong influencing, relationship building, mentoring & networking skills
Proven track record in performing & leading internal and external audits.
Exceptional analytical, problem solving & root-cause analysis skills
Locations: Israel; Haifa
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf . 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.