Summary

This position is responsible for ensuring quality and regulatory compliance of a large facility, while driving process efficiency. The position provides key leadership to support the Supply Chain Activities at the Site, including Production and Process Control, Lean, and Supplier Quality. He/she represents GEHC to external agencies and champions the evolution of the quality culture for the site which includes driving site quality objectives, metrics, reporting and operating mechanisms.

Roles and Responsibilities

• Influences quality system metrics such as Corrective and Preventive Action, training metrics, completion, and complaint resolution metrics
• 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)
• Ensures site audit readiness and hosting Quality System audits and inspections
• Reports on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews
• Oversees the Corrective Action / Preventive Action activities and Complaint Handling Programs
• Maintains and improves all aspects of Site Quality Planning
• If managing a team, provides leadership and facilitates problem resolution, resource utilization, career counseling, mentoring and development of team members
• Maintains positive agency relationships-liaisons with regulatory agencies upon site inspections and participates in external technical forums
• Accountable for ensuring full quality and regulatory compliance of a facility, while driving process effectiveness and efficiency at the site
• Oversees all Quality-related communications and training requirements for all site employees
• Drives the definition of site quality objectives, metrics, reporting and operating mechanisms
• Participates in selected global initiatives to share best practices and leverage quality synergies.
• 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
• Ensures site audit readiness and hosts the Quality System audits; prepares and executes Quality Management System reviews
• Supports local NPI programs and quality issue resolution
• Influences site compliance to Quality policy, Quality Management System procedures, and Quality Star guidelines

Required Qualifications

• 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.
• Demonstrated experience using word processing, spreadsheet, and presentation software.
• Ability to communicate effectively in English (both written and oral).
• Hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements.
• 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 1 year supervisory/management or project leadership experience.

Desired Characteristics

• Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
• Demonstrated collaboration & conflict resolution skills
• 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
• Proven process development and project management skills
• Experience in a global, matrixed organization structure
• Exceptional analytical, problem solving & root-cause analysis skills
• Minimum of 5 years supervisory/management experience is preferred
• Experience leading, implementing, and accelerating change
• Excellent communication skills (written and oral)
• Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
• Proven track record in performing & leading internal and external audits
• Strong influencing, relationship building, mentoring & networking skills

For U.S. based positions only, the pay range for this position is $132,000 - 198,000. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

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.

While GE Healthcare does not currently require U.S. employees to be vaccinated against COVID-19, some GE Healthcare customers have vaccination mandates that may apply to certain GE Healthcare employees.

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