US-Illinois-Rockford: QA Compliance Specialist
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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.
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Team SQAFYI - Software QA Resource FYI