SQAFYI - Software QA Resource - FYI

US-Illinois-Rockford: QA Compliance Specialist

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 14-Feb-2014

QA Compliance Specialist

Develop and perform software validation protocols in compliance with regulations and write validation reports Effectively communicate with other departments on quality and compliance issues Participate in vendor, customer, registrar and regulatory audits Participate in and lead quality and process improvement projects. Prepare, revise and implement relevant SOPs related to the QMS. Review and approve product and process deviations. Develop and conduct annual QMS and regulatory training Properly interpret and apply regulatory requirements. Review batch documentation and perform product release for regulated products

1+ years of experience in Quality Assurance for the medical device or pharmaceutical industry.

Must have experience working with and managing multiple projects and teams simultaneously. Experience auditing required Ability to analyze statistical data, interpret results, and process proposed document changes and validation. Proficient in data analysis with experience using problem solving tools Excellent written and verbal communication skills Experience with FDA inspections preferred. Demonstrated ability of influence and persuasive management skills Demonstrated ability to work collaboratively with production and operations staff to drive QMS improvements and deliver necessary compliance requirements while maintaining a collaborative environment between functional areas. Experience performing software validation, including development of plans and reports Customer service oriented skills are required as this position requires cross-functional interaction, both internally and externally.

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI

US-Illinois-Rockford: QA Compliance Specialist