Regulatory Compliance Analyst I
Posted on 11/10/2022
INACTIVE
Plexus

5,001-10,000 employees

End-to-end product realization solutions
Company Overview
In order to provide seamless product realization, Plexus has been partnering with companies around the world to transform their concepts into branded products and deliver them to the market with customer service like you’ve never seen in the electronics manufacturing industry.
Industrial & Manufacturing

Company Stage

N/A

Total Funding

N/A

Founded

1979

Headquarters

Neenah, Wisconsin

Growth & Insights
Headcount

6 month growth

2%

1 year growth

5%

2 year growth

15%
Locations
Wheeling, IL, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
CategoriesNew
Legal & Compliance
Requirements
  • A minimum of a Bachelor's degree in Engineering is preferred
  • Two (2) years of related experience is required
  • Individual typically has 2 to 4 years' experience in an engineering, technical, quality function role or equivalent
  • Experience in product regulatory and medical device standards (FDA QSR, ISO 9001/13485/14001, etc.) is required
  • Intermediate Computer Skills
  • Intermediate Decision Making, Problem Solving Skills
  • Intermediate Verbal and Written Communication Skills
  • Advanced Execution
  • Intermediate Operational and Industry Knowledge
  • Advanced Decision Making & Problem Solving
  • Intermediate Influence
  • Advanced Communication
  • Basic Workmanship Standard Knowledge
  • Customer Focus
  • General office equipment and materials
Responsibilities
  • Assures ongoing regulatory compliance for all documentation including Assembly Build Instructions, Device travelers, Certificates of Compliance, Compliant Files, DMR's DHR's, etc
  • Supports reviews of and compliance to external standards and regulations
  • Supports the design and installation of the quality system at the site
  • Support and or lead the training of all applicable standards (ISO, medical regulations, etc.)
  • Supports the coordination of training to quality system documentation (SOP, Quality Plans, Work Instructions)
  • Supports Process Validation/CAPA documentation and Implementation