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Risk Manager-Cyber Security job

GE HealthcareWaukesha, WI
GE Healthcare jobs

Company

Salary

Company Description

GE Healthcare is a multinational conglomerate firm that produces medical equipment. The firm offers monitors, scanners, dispensers, displays, imagers, recorders, analyzers, separators, and medical and laboratory medical equipment for medical industries. GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. The company's broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, biopharmaceutical manufacturing technologies, drug discovery, performance improvement, and performance solutions services help its customers deliver better care to more people worldwide at an affordable price. GE Healthcare was founded in 1994, and its headquarter is based in Chicago, Illinois, United States. The company partner with healthcare leaders who strive to leverage the global policy change required to successfully shift to sustainable healthcare systems. GE Healthcare provides healthcare benefits and other perks to its employees.

Job Description

The Risk Manager-Cyber assesses cyber-security risk associated with the use of
medical devices designed and/or manufactured by GEHC. Risk Management is an
integral part of the product development process over the commercial life of
the product & includes identifying hazards, estimating, evaluating &
controlling risk & monitoring the effectiveness of the control of risk. The
Risk Manager-Cyber implements, improves, & directs risk management programs,
processes & procedures across product lines.

Job Responsibilities
* Develop processes to effectively identify and assess safety risks
associated with cyber-security vulnerabilities in medical devices.
* Work closely with the GEHC cyber-security team to establish coordination
between the two organizations to ensure timely and effective
identification and resolution of vulnerabilities; participate in
established vulnerability triage process to ensure continued connection
between quality and cyber-security.
* Develop and implement systematic approach to identify standardized risk
association between digital and physical components.
* Assist in improving complaint handling system to ensure capture of cyber-
security related entries.
* Work with cross-functional cyber-security and product teams to identify
potential structural product improvements to reduce potential future
risks.
* Develop management reports to qualify and monitor risks to ensure risk
responses are timely and effective
* Determine the most effective methods for handling risk exposures and
recommend mitigation to senior management
* Decompose hazards into lower level hazards and hazardous situations
* Total product lifecycle monitoring - linking product development risk
management to post-market risk assessments
* Identify and drive improvements to overall Risk Management processes and
documentation to provide clear flow down of regulations
* Educate, train, advise and coach business leaders and QA/RA practitioners
on the related regulations, procedures and work instructions
* Work closely with the Clinical/Medical professionals to assure their
input is foundational to the hazards and harm inputs to risk management
* Assure probability of occurrence is consistently applied during failure
investigation and risk Analysis
Basic Qualifications
* Bachelor Degree in scientific / clinical discipline or engineering, and a
minimum of 5 years of progressively more responsible Quality Assurance or
Regulatory Affairs experience in the medical device, pharmaceutical,
chemical or banking/financial security industry; OR high school diploma/
GED and a minimum of 12 years of progressively more responsible Quality
Assurance or Regulatory Affairs experience in the medical device,
pharmaceutical, chemical or banking/financial security industry
* A minimum of 3 years of Risk Management experience in the medical device,
pharmaceutical, chemical industry including experience facilitating risk
working sessions
* Experience with Risk Management standards (ISO 14971 for medical devices
and ICH Q9 for pharmaceuticals)
* Strong technical background in system architecture, specifically related
to interaction between digital and components in relevant field.
* Knowledge of risk management methods and practice, cost/benefits
analysis, and risk models and project management practices
* Experience with risk management tools such as FMEA, FTA, HAZOP, fish-bone
diagrams, and robust design techniques
* Strong analytical skills
* Demonstrated knowledge of Quality Management Systems and experience
linking risk management to all elements of the Quality System (Design
Controls, CAPA, P&PC, Complaints, Document Control, etc)
* Demonstrated experience with ISO, GxP, FDA or other key regulatory bodies
* Ability to communicate effectively in English
* Prior experience using word processing, spreadsheet, and presentation
software
Desired Qualifications
* Working knowledge of ISO 14971 - Medical Device Risk Management
Standards, and ICH Q9 Pharma Risk Management Standard
* Demonstrated experience leading and facilitating change
* Demonstrated experience working in a cross-functional environment and
proven ability to influence and build consensus among multiple functions
including but not limited to engineering, operations, regulatory affairs,
and medical affairs
* Knowledge of product family and P&L organization
* ASQ Certification as Quality Engineer (CQE), Quality Manager (CQM),
Operations Excellence (OE), or other related discipline
* Demonstrated compliance program management/leadership experience. Able to
prioritize, plan, delegate and evaluate deliverables to established
strategic goals
* Demonstrated process/lean skill to drive project execution with
discipline
* Demonstrated collaboration, negotiation & conflict resolution skills.
Ability to build a connection with the team through personal involvement
& trust & providing feedback & coaching to help develop others
* Visibly demonstrates comfort & efficacy in presenting to and in
communicating with top organizational leadership & internal & external
customers, responding in a professional manner
* Familiar with classic quality tools & experienced in applying them to
monitor function performance
* Global regulatory experience & demonstrated experience interfacing with
FDA
* CISSP Preferred
Estimated annual salary
$67,024
average
Minimum
$48,934
Maximum
$100,037

GE Healthcare

Type

Subsidiary

Size

Large

Revenue

Over $10B

Location

3000 North Grandview BoulevardWaukesha, WI, 53188and others

Founded

1892

CEO

John L. Flannery

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