General Electric QA Leader in Arlington Heights, Illinois
Job Description Summary
The QA Leader is responsible for ensuring quality and regulatory compliance of a large and/or multi-modality facility, while driving process effectiveness and efficiency.
At GE Healthcare, our machines, our software, our solutions, our services, and our people make a genuine difference to medical professionals and patients all over the world. That’s because we never lose sight of what healthcare really needs—the human touch.
Accountable for ensuring full quality and regulatory compliance of a facility, while driving process effectiveness and efficiency at the site
Manage the Raw Materials Quality Control team: provides leadership and facilitates problem resolution, resource utilization, career counseling, mentoring and development of team members
Ensures site audit readiness and participates in Quality System audits.
Has authority to stop production, issue product holds (stop orders), make decisions people accountability, release products and sign off on project milestones (i.e. New Product Introduction)
Ensures site audit readiness and supporting Quality System audits and inspections
Oversees the Corrective Action / Preventive Action activities .
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
Participates in selected global initiatives to share best practices and leverage quality synergies
Bachelor's Degree or Associates Degree with 10+ years work experience.
5+ years working in a regulated medical device or pharmaceutical industry.
1+ years supervisory/management or project leadership experience
Hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements.
Minimum of 5 years supervisory/management experience is preferred.
Proven process development and project management skills.
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.
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
Proven track record in performing & leading internal and external audits.
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 you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer (https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.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.
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 drug screen (as applicable).
Relocation Assistance Provided: No