Documentation and Design Controls Specialist

Posted 3 Days Ago
Be an Early Applicant
Madison, WI
Mid level
Artificial Intelligence • Healthtech • Analytics • Biotech
The Role
Support engineering and manufacturing with compliant documentation, partner with stakeholders to maintain product definitions, and participate in quality improvement activities.
Summary Generated by Built In

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

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: No

Top Skills

Creo Parametric
Dassault’S Enovia
Lean
MS Office
Oracle Analytics Server
Six Sigma
Windchill
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The Company
Chicago, IL
50,282 Employees
On-site Workplace
Year Founded: 1892

What We Do

Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence.

As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform.

With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.

We embrace a culture of respect, transparency, integrity and diversity.

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