Documentation and Design Controls Specialist

Job Description SummarySupport Engineering and Manufacturing operations with activities contributing to quality-and-regulatory-compliant, effective, and efficient documentation within the Engineering Process and Data Quality team of GE HealthCare’s Anesthesia and Respiratory Care business unit.

Job Description

Roles and Responsibilities:

• Actively contribute to our data/documentation assembly process – consulting, authoring, content auditing, approval routing, and workflow advancement
• Partner with team members and stakeholders to create and maintain high-quality item definitions, product structures, and configuration/compatibility matrices
• Obtain technical information from subject matter experts and establish reproducible method for generating clear and concise documentation in accordance with professional standards
• Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible
• Support global Trade Compliance at GE Healthcare by assisting with inquiries.

Quality Specific Goals:

Aware of and comply with the GE HealthCare’s Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position Knowledge and understanding of GE HealthCare Design Controls Procedures to ensure that specified design requirements are met

Qualifications:

Required Qualifications:

•   Bachelor’s degree in Engineering, Information Management, Data Science, or Technical Writing /or/ an Associate’s degree with 6 years of experience working in an Engineering related field or Quality Assurance role /or/ a high school degree with 10 years of experience working at a medical device manufacturer or similar FDA-regulated business.

  •   Strong attention to detail.

  •   Desire and ability to participate in a fast-paced, global team (requires flexibility for some early morning / late evening meetings).

  •   Minimum of 3 years authoring and reviewing content with Microsoft Office (Outlook, Word, Excel, Visio).

  •    Experience with document control processes, familiarity with electronic document management systems.

Preferred Qualifications:

• Experience working in the medical device industry
• Strong attention to details
• Proficiency in advanced Excel skills, including pivot tables, VLOOKUP, XLOOKUP, and conditional formatting.
• Experience with Lean, Six Sigma, or continuous process improvement
• Experience working with global teams and project timelines
• Experience with Dassault’s Enovia Product Lifecycle Management tool
• Experience with Oracle Analytics Server: Query, Reporting, Analysis, Dashboard Management
• Experience with PTC’s Creo Parametric and Windchill Product Data Management tools
• Knowledge in GE Healthcare global standards

Additional Information

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.