The Quality Assurance Specialist supports quality systems processes and produces and reviews quality records.
• Work with quality systems teams to run reports, create, track, and analyze metrics, facilitate meetings, and document meeting actions
• Author, route, and/or review quality systems records for submission to both internal and external customers
• Assist in investigating quality issues, as required
• Monitor and maintain compliance to existing quality system processes
• Assist in internal and external audits
• Assist in authoring and/or routing changes to quality system processes
• Must work and interact effectively and professionally with and for others
throughout various levels of the global organization
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have excellent oral and written communication skills, specifically related to technical writing
• Ability to work in collaborative and
independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations
• Must have excellent organization and prioritization of tasks
• Bachelor’s degree ; or 5 - 8 years experience of such kind and amount as to provide a comparable background
• Knowledge of Cook Inc. quality systems, associated documentation, and product lines
• Knowledge of medical device regulations, including pertinent standards and guidances
• Computer literacy and proficiency (Word, excel, Adobe etc.)
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