Regulatory Temp

Last updated 40 minutes ago
Location:Andover, Minnesota
Job Type:Full Time

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.

PRINCIPLE ACCOUNTABILITES

  • FDA, NB, Third Party audit coordination and support
  • Internal auditor
  • Quality reporting and Management review prep
  • Medical CAPA, CCAR, RMA assistance, notifications, and trending
  • Quality System Trending support
  • Post market Surveillance support
  • MDR vigilance reporting support
  • Establishment registration
  • Product listing
  • Labeling support
  • Regulatory submission support
  • Front room scribe (for FDA)
  • Standards upkeep and yearly revision audit
  • Adhere to stated policies and procedures relating to health and safety, and quality management i.e. ISO and Corporate.
  • Other duties as assigned by manager

JOB REQUIREMENTS

  • Must be US person or PRC holder due to access to products and technology controlled under the ITAR & EAR.
  • Familiar with formal quality system assessments (i.e. ISO 9001, ISO13485:2016/MDSAP).
  • Must be able to read and follow all written and implied directions, policies and procedures.
  • Ability to analyze and resolve problems using various failure analysis techniques to isolate failures down to the root cause.
  • Good organization, verbal, writing and listening skills.
  • High level of attention to detail and accuracy.
  • Work independently in a team environment.
  • Must be proficient with Microsoft Office applications (Word, Excel, PPT, etc.).

EDUCATION & EXPERIENCE

  • 2-year degree preferred
  • 2-4 years’ experience in Medical Industry
  • This individual must be self-driven, results-oriented with a positive outlook and a clear focus on quality.
  • Comfortable in dealing with employees at all levels. Good communicator and customer friendly.
  • Must be proficient in use of MS Office Excel, Word, Access, and PowerPoint.
  • Good communication and computer skills, including data analysis and report writing skills
Job Overview
TE Connectivity's Quality Assurance Teams are responsible for all or part of an organization's Quality Management System, including conformance and continuous improvement initiatives. They work on systemic evaluation of products, services, facilities, manufacturing or business processes, to ensure that standards of quality are being met. Develop and implement quality plans, programs and procedures using quality control statistics, lean manufacturing concepts, and six-sigma tools and analyses. They reviews, analyze and report on quality discrepancies, investigate problems and executes quality audits, and develops disposition and corrective actions for recurring discrepancies. The team works closely with manufacturing, engineering, customers, or suppliers and subcontractors to ensure requirements are met.
What your background should look like:
Competencies
Values: Integrity, Accountability,Teamwork, Innovation