Quality System Process Lead (CAPA)

Business Unit: GE HealthcareFunction: QualityResponsibilities: -Quality oversight, facilitation and monitoring of the Formal Investigation and Corrective Action / Preventive Action (CAPA) program within the Molecular Imaging and Computed Tomography business unit.
Work with Design Engineering, Product Complaint Processing, and Manufacturing on process/product improvement projects.
Lead projects involving detailed definition, cause analysis, and validation of process/product improvement initiatives.
Candidate must be a subject matter expert in the application of CAPA program requirements within product design and manufacturing environments. Must have solid organization, problem solving, decision-making judgment, and leadership skills. Must have demonstrated working knowledge of FDA and ISO medical device regulations and practices. Must be proficient in the use of appropriate cause analysis and statistical tools and techniques such as root cause analysis, fishbone diagrams, FMEA, DOE, ANOVA, Cpk, etc. Candidates must be:
Proficient in the use of PC applications such as MS Word, Excel, Access, Power Point, Adobe PDF Reader, Visio and Outlook.
Able to work well on their own and possess global skills to manage teams and drive compliance in a highly matrixed organization.
Successful at interfacing with both internal and external customers as well as top organizational leadership.
Experienced with change control process workflow and documentation requirements in a regulated environment.
REQUIREMENTS
Qualifications: * Bachelors degree in relevant technical discipline
5 years experience in a medical device or pharmaceutical GMP regulated environment
Continuous improvement project experience within product design and/or manufacturing disciplines
Experience performing internal quality system audits
Experience with development and maintenance of CAPA monitoring and tracking databases
Design controls, and/or design verification and validation experienceDesired: Six to ten years experience including, parts of the following:
Responsibility for continuous improvement projects within product design and/or manufacturing disciplines.
Performing internal quality system audits.
Experience with development and maintenance CAPA monitoring and tracking databases.
Design controls, and/or design verification and validation activities.
Strong global communication skills
Black belt six-sigma ceritification.General: Quality oversight, facilitation and monitoring of the Formal Investigation and Corrective Action / Preventive Action (CAPA) program within the Molecular Imaging and Computed Tomography business unit.
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