Manager, Quality, PPC - Surgery
At a glance
Mid-level Paid Search / PPC role at Gehc. Salt Lake City · full-time.
Pay not stated Paid Search / PPC salary
Growth Roles summary, based on the employer's posting.
What you'll do
- You lead site quality planning, compliance, metrics, reporting, and operating routines across production and supply chain work
- You oversee audits, inspections, agency relationships, employee training, and quality communications
- You manage CAPA work and report on the quality system’s effectiveness to site leaders
- You supervise quality staff while improving processes and supporting product release and project milestone decisions
What you bring
- You bring a bachelor’s degree and six years in regulated medical device or pharmaceutical work, or ten years with a high school diploma
- You have at least two years leading people or projects, with five years preferred for supervisory or management work
- You understand medical-device quality systems and regulations, including FDA CFR 21 820 and ISO 13485
- You have hands-on experience with FDA, QSR, ISO, MDD, or other international quality-system requirements
Who this fits
You’ll fit this role if you can lead quality teams, influence multiple functions, manage audits, and guide compliance during change or crisis. The position is based in Salt Lake City and includes direct reports. GE HealthCare will not sponsor employment visas, and applicants must already be legally authorized to work in the United States. Relocation assistance is provided.
From the employer
Job Description 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. 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.Job Description
Roles and 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
Required Qualifications
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
Desired Characteristics
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
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. 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 HealthCare 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).
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.
Relocation Assistance Provided: Yes
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