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.
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
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
- 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
Total Quality Management
Provide Technical Guidance