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Quality Assurance Specialist

Integrated Resources, Inc Milwaukee Contractor
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Job Title  :Quality Assurance Specialist

Job Location: Milwaukee ,WI

Job Duration:6+ months(possible extension)

Role Summary :

This position within the QA department supports product release of medical devices through the review of key documentation and facilitates continuous improvement of manufacturing of medical devices.

Responsibilities :

  • Review production documentation and assist with batch release procedures
  • Support the timely release of product to market
  • Liaise with Operations personnel to ensure regulatory and quality requirements are met and understood during routine operations
  • Responding to routine quality related queries from other departments
  • Supporting the ongoing deviation / corrective action program
  • Liaising with other departments to allow closure of corrective actions
  • Monitoring and aiding the implementation of continuous improvements and process changes to ensure that these are implemented in compliance with GMP.
  • Participating in audits, together with follow up.
  • Conducting QA activities including revision of SOPs, SAP QA work and the issuance of protocols.
  • Review, Approval and Reporting Activities related to the QMS
  • Attending a number of cross functional team meetings / projects

Qualifications :

B.S. Degree in business or technical field or equivalent experience and 1-year or more experience in a medical device or regulated industry; or Associate degree and 3 years or more of experience in a medical device or regulated industry; or 5 years or more of experience in a medical device or regulated industry

Knowledge of relevant Electronic Management Systems transactions and familiarity with Excel / Word packages

Characteristics :

  • Experience developing and tracking quality metrics
  • Familiar with Continuous Improvement methodologies, including Six Sigma and/or Statistics education and or training
  • Detail oriented and highly organized
  • Excellent interpersonal skills

Skills required

Sample Procedure
Quality Assurance
Performance Testing
Perform Inspection
Total Quality Management
Provide Technical Guidance


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