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CAPA Manager- Medical Devices in Schaumburg, Illinois

Schaumburg, Illinois Jobs

60196 Jobs

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data analysis




Job Description

  • Manage Investifgative team members
  • Ensure that the training of all direct reports is up to date
  • Perform time and attendance activities
  • Conduct performance reviews
  • Ensure that the department has adequate resources to carry on activities
  • Represent QA at all project team meetings
  • Lead Risk Management activities
  • Ensure that the Design Transfer activities are done
  • Coordinate all process validations for both mechanical and chemical operations
  • Support equipment qualifications for both mechanical and chemical operations
  • Lead the development of test methods for new product designs
  • Write testing protocols as necessary
  • Ensure that the First of Code activities are performed correctly
  • Summarize test data using complex data analysis tools
  • Lead CAPA projects
  • Coordinate investigation for customer complaints
  • Perform process capability studies and gage R&R
  • Integrate external standard requirements into internal procedures
  • Ensure that all Standard Test Methods are up to date
  • Develop facility quality performance reports, charts, and graphs
  • Coordinate product studies and evaluation reports
  • Visit contract manufacturers and perform GMP audits
  • Support Quality Management Systems
  • Lead six sigma projects
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individuals status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • 5 years experience in medical quality role
  • 5 years experience in quality
  • FDA Remediation experience
  • Excellent Communication Skills
  • Out Going personality
  • Able to Work cross functionally with multiple departments in tandem.
  • Conflict Resolution skills
  • Comfortable being a leader and taking initiative
  • Knowledge and implementation experience with Continuous Improvement Methodologies (Six Sigma, 5S, Lean Mfg. , etc.) required, certifications preferred
  • Proficient in MS Office (Excel, Word and PowerPoint and Outlook) required

Whats on Offer

  • Competitive Salary- $110,000 to $125,000
  • BCBS health
  • Vision and Dental coverage
  • 401K match
  • Staff events
  • On campus Gym and walking trails
  • Bonus- 12

Job ID: 5110625325050033966



CAPA Manager- Medical Devices in Schaumburg, Illinois

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This job is located in

Schaumburg, Illinois, 60196