Project Coordinator

Integer Holdings CorporationPlymouth, MN

About The Position

Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets. As a strategic partner of choice to medical device companies and OEMs, Integer is committed to enhancing the lives of patients worldwide by providing innovative, high-quality products and solutions. The company's brands include Greatbatch Medical® and Lake Region Medical®. At Integer, values such as Customer, Innovation, Collaboration, Inclusion, Candor, and Integrity are embedded in everything they do, creating a unified culture. This role involves adhering to Integer’s Values and all safety, environmental, security, and quality requirements, including Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies, and operating procedures.

Requirements

  • Bachelor’s Degree or commensurate experience
  • 3-5 Years Minimum Experience
  • Reliance or similar ERP system knowledge 3-5 years of experience
  • Microsoft office products knowledge 3-5 years of experience, comfortable with Excel spreadsheets
  • Excellent written and communication skills able to communicate to multiple organization levels
  • Highly organized with the ability to work independently and within a team

Nice To Haves

  • Manufacturing experience preferred

Responsibilities

  • Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
  • Compiles documents submitted by R&D associates for CR submission
  • Ensures the documents & attachments meet minimum requirements (correct templates, proper formatting, etc.) and compiles with governing quality documents before submitting
  • Work with doc control team to make sure any additional corrections necessary before changes can route for approval
  • Clearly communicate issues with submissions to requesters as needed
  • Tracks CR progression and follows up with approvers on a regular basis to facilitate timely release of CRs
  • Creates and maintains a CR log for R&D associates to easily track CR closures and communicate reasons for delay or rejection
  • Other duties as assigned

Benefits

  • base salary
  • cash-based incentive program
  • comprehensive benefits package with immediate eligibility
  • medical insurance
  • dental insurance
  • vision insurance
  • disability insurance
  • life insurance
  • adoption benefits
  • Parental leave is available after one year
  • Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance
  • Employees are immediately eligible to participate in the 401(k) plan with company matching contributions
  • 80 hours (10 days) of company designated holidays per year
  • annual allotment of paid time off
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