Manager, Quality, PPC - Surgery

GE HEALTHCARE•Salt Lake City, UT

About The Position

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. This position 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.

Requirements

Bachelor’s degree and minimum of 6 years working in a regulated medical device or pharmaceutical industry (or a high school diploma with 10+ years working in a regulated medical device or pharmaceutical industry)
Minimum of 2 years supervisory/management or project leadership 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

Nice To Haves

Minimum of 5 years supervisory/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
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
Demonstrated collaboration & conflict resolution skills
Proven track record in performing & leading internal and external audits
Exceptional analytical, problem solving & root-cause analysis

Responsibilities

Ensures quality and regulatory compliance while driving process effectiveness and efficiency.
Represents GE HealthCare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
Maintains and improves all aspects of Site Quality Planning
People leader with direct reports. Deep expertise within quality to drive compliance and continuous improvement in Quality processes. Provides professional or thought leadership. Influences policy and ensures delivery within Quality, linking with other functions of the organization.
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
Supports the Corrective Action / Preventive Action activities and Reports on Quality System effectiveness and requirements to management team as required.
Drives the definition of site quality objectives, metrics, reporting and operating mechanisms