Senior Quality Engineering Specialist

About the Role

Key Responsibilities

• 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.

Requirements

• 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.).